EXPRESS

The Pragmatic Critical Care Research Group (PCCRG) is a network of emergency medicine, anesthesiology, and critical care clinicians and researchers at more than 25 hospitals across the United States that embeds pragmatic trials within clinical care to improve outcomes for acutely ill patients.

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Current Trials

Posted on

EXPRESS

Jun 2026
Posted on by briserv

What We Need To Learn

Each year, millions of people in the U.S. become critically ill and requiresupport from a breathing machine (invasive mechanical ventilation).  About 25-35% of critically ill adults on a breathing machine die in the hospital. For all patients on a breathing machine, clinicians adjust the amount of oxygen patients breathe in to keep the patients’ oxygen levels (SpO2) in a safe range. Higher oxygen targets (96-100%) can protect against low oxygen levels in the blood but could cause damage from too much oxygen. Lower targets (88-92%) may prevent the risks of too much oxygen but could increase the chance of damage from too little oxygen. Recent studies, including one at Vanderbilt, showed no overall difference in outcomes between higher and lower oxygen targets for patients on a breathing machine. However,  the best approach to oxygen therapy may depend on a patient’s unique characteristics, like age or medical condition. Researchers are Vanderbilt created a model using data from 24 patient characteristics that predicts which oxygen level will result in the best outcomes for each individual patient. Early tests suggest that using such a “personalized oxygen target” could save lives, but a trial is needed to confirm this. The EXPRESS trial will examine the use of a “personalized oxygen target”. If a “personalized oxygen target” is proven to improve patient outcomes, it could help millions of patients worldwide.

What We Are Doing

This research study is called Examination of PeRsonalizEd SpO2 TargetS (EXPRESS).  It is being conducted in the medical intensive care unit (ICU) at Vanderbilt. The goal of the study is to learn whether using a “personalized oxygen target” based on each patient’s unique characteristics can improve survival compared to the clinicians managing oxygen therapy as they would in care today outside of research.

Participating in this study will not impact the quality of care patients receive. For each patient:

  • When doctors determine a specific oxygen target is needed for a patient’s care, the patient will not take part in the study, and the doctors will use the oxygen target they believe is best.
  • When doctors determine that either a “personalized oxygen target” or clinicians managing oxygen therapy as they would in care today outside of research would be equally safe and effective, the patient will be enrolled in the EXPRESS study. The EXPRESS study will randomly choose if the patient is in the personalized oxygen target group or the group in which clinicians manage oxygen therapy as they would in care today outside of research.
  • If, at any time, the doctors decide that a different oxygen approach is needed for the patient’s care, they will adjust the oxygen therapy and document the reason for change.

For patients in the personalized oxygen target group, clinicians will receive information from a statistical model predicting the best range of oxygen values for each patient. Clinicians will use this information to choose an oxygen target for the patient. Nurses and respiratory therapists will adjust the oxygen given minute-by-minute to maintain the chosen oxygen target.  For patients in the other group, clinicians will manage oxygen therapy as they normally would, without receiving information from the statistical model.

Frequently Asked Questions

Who is eligible for the EXPRESS study?

Patients who are receiving invasive mechanical ventilation in the Vanderbilt medical ICU whose doctor determines that a specific approach to oxygen therapy is not required for the optimal care of the patient. Patients can only participate if they are receiving invasive mechanical ventilation in the medical ICU at Vanderbilt. They cannot volunteer at any other time.

What is oxygen therapy?

Oxygen therapy is a treatment that gives you extra oxygen to help you breathe better. It is often used when your body isn’t getting enough oxygen on its own, such as when you are sick or have trouble breathing. The oxygen is delivered through tubes in your nose, a mask, or a machine that helps you breathe. It helps your body work properly by making sure your organs and tissues get the oxygen they need.

How does the statistical model predict what oxygen level is best for each patient?

The statistical model uses information about the patient, like their age, heart rate, blood pressure, and other health details, to figure out the best oxygen level for them. It looks at 24 different factors, which are all taken from the patient’s records when they start using a ventilator. The model combines all this information to predict whether a higher oxygen target (like 98%) or a lower oxygen target (like 90%) will help the patient the most. This helps doctors decide the best oxygen level for each patient.

We want to know what you think about the EXPRESS study

We welcome feedback and questions about research studies like this. If you have comments or questions please contact Dr. Matthew Semler at matthew.w.semler@vumc.org or (615) 933-6994.

This work is supported through a National Heart, Lung, and Blood Institute (NHLBI) award (R61HL180352-01)

Current Trials

Posted on

ECMO -FREE

May 2026
Posted on by briserv

What we need to learn

When people become very sick and their lungs cannot give the body enough oxygen, they may need help from a machine that works like an external lung. This machine, called Veno‑Venous Extracorporeal Membrane Oxygenation (V-V ECMO), takes blood out of a patient’s vein, pushes oxygen into the blood and pulls carbon dioxide out of the blood, and returns the blood to the patient’s vein. While V-V ECMO saves lives, patients receiving V-V ECMO may also experience severe complications. Doctors try to take patients off V-V ECMO at the earliest time that it would be safe to do so. Hospitals use different methods to determine when to remove patients from VV-ECMO, but there is little research showing which approach works best.

A small study conducted at Vanderbilt Health suggested that checking every day to see if a patient is ready to come off V-V ECMO might help doctors stop the treatment sooner, without added risk. We need to test this idea in many hospitals to understand if daily protocolized check-ins can help patients stop V-V ECMO sooner, decrease complications, and improve recovery.

What we are doing

This research study is called ECMO-Free: A Multicenter Controlled Trial. The goal of the study is to learn whether a step-by-step daily protocol to check if patients are ready to stop V-V ECMO (called the ECMO-Free protocol) is better than usual care. Usual care varies from hospital to hospital and often depends on a doctor’s judgement, which can sometimes underestimate when a patient is ready to stop V-V ECMO. The daily ECMO-Free protocol uses a step-by-step approach to gradually decrease the support from V-V ECMO. Patients are monitored very closely during the entire process. If, at any time, their doctors determine that they should not continue to the next step, they will stay on V-V ECMO. This study will compare use of the daily ECMO-Free protocol to usual care to learn which approach helps patients come off V-V ECMO more quickly and safely.

This research is taking place in eight hospitals across the United States and Canada.  Patients on VV-ECMO may be eligible to participate if they or their decision-makers consent to take part.

Participating in this study will not impact the quality of care patients receive. For each patient:

  • If doctors think usual care is best for a patient, they will use those methods, and the patient will not take part in the study.
  • If doctors think that either the daily, step-by-step protocol (ECMO-Free protocol) or usual care would be equally safe and effective for the patient, the patient or a family member will be approached for consent to be enrolled in the ECMO-Free Trial. If the patient or family member agrees to participate in the trial, the strategy to stop VV-ECMO will be randomly chosen by the study.
  • If, at any time, doctors decide to not follow the daily, step-by-step ECMO-Free protocol and a different approach is needed for the patient’s care, they will treat them as they feel appropriate and document the reason for change.

Participating Sites

  • Vanderbilt Health
  • Baylor University Medical Center
  • Hennepin County Medical Center
  • Stanford University Medical Center
  • Texas Tech University Health Sciences Center El Paso
  • Toronto General Hospital
  • University of California, San Diego Health
  • University of Utah Hospital

FAQs

What is V-V ECMO?

V-V ECMO stands for Veno‑Venous Extracorporeal Membrane Oxygenation. The V-V ECMO machine works like an external lung by adding oxygen to the blood and removing carbon dioxide, which you normally breathe out. This machine is used for patients when their lungs cannot work well enough on their own, allowing their lungs to have time to recover.

What are the risks of the ECMO-Free trial protocol compared to usual care?

V-V ECMO is a complex but life-saving treatment. Patients on V-V ECMO are at risk of bleeding, blood clots, infection, or other complications. All of these risks are present no matter the method used to decide when to safely stop V-V ECMO.

Who is eligible for the ECMO-Free study?

  • Adults who are receiving V-V ECMO in a participating hospital and are not receiving V-V ECMO as a bridge for transplant. People cannot volunteer to participate in the study at any other time

  • Patients are eligible only if their doctors and nurses think that using either the ECMO-Free daily, step-by-step protocol or usual care to determine when V-V ECMO should be stopped would be consistent with optimal care for them.

Patients are eligible only if their doctors and nurses think that using either the ECMO-Free daily, step-by-step protocol or usual care to determine when V-V ECMO should be stopped would be consistent with optimal care for them.

Current Trials

Posted on

MODEM

May 2026
Posted on by briserv

What we need to learn

Seriously ill patients sometimes need a breathing machine to help them breathe.  Doctors or respiratory therapists select settings on the breathing machine that determine how the patient receives each breath – referred to as the “mode”.  Three modes are common: volume control, pressure control, and adaptive pressure control. All 3 are considered safe and effective, but it is not known if one breathing machine mode is better than the others.

What we are doing

This research study is called the “Mode of Ventilation During Critical Illness at Multiple Center” (MODEM) and is funded by the National Heart Lung and Blood Institute (NHLBI). Our goal is to compare three different modes used on breathing machines to understand if one mode is better for helping patients recover. For all patients on a breathing machine in this ICU:

  • When the healthcare team feels they know which mode is best for a patient, they use that mode.
  • When the team does not know which mode would be best, doctors and respiratory therapists use the mode assigned to the ICU for that month – a computer has assigned the ICU to use a mode for each month randomly (which means each patient in the ICU has a fair and equal chance of receiving any of the three modes).
  • When you or your loved one is on the breathing machine, the study will collect data about the person on the breathing machine, their care and their condition. The study will continue to follow them until they are discharged to collect data about their recovery.

All three modes are commonly used to care for patients on a breathing machine. Current guidelines do not recommend using one more than the others.

Participating in this study will not impact the quality of care patients receive. For each patient:

  • All three ventilator modes were commonly used in the care of patients prior to the start of the trial.
  • During the trial, all patients admitted to the study ICU in a given month will receive the same ventilator mode, determined by the trial. The goals for the safe size and pressure of breaths from the breathing machine will be the same
  • If at any time clinicians feel that a different mode is optimal for their care, the doctors or respiratory therapists can change to use that mode.

The study team will

  • Check in with clinical teams during the study to ensure they feel comfortable using the mode assigned by the study for each of their patients.
  • Confidentially review the medical record of all eligible patients

Questions

If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Kevin Seitz at kevin.seitz@vumc.org or (615) 936-9329. If you have questions about your rights as a research participant, or concerns or complaints about the research, you may also contact the Vanderbilt Human Research Protections Program at (615)- 322-2918.

Participating Sites

  • Johns Hopkins Hospital
  • Rush University Medical Center
  • Vanderbilt Health
  • Wake Forest Atrium Health

Frequently Asked Questions

What is a breathing machine?

Some seriously ill patients in the hospital need help breathing. In this situation, a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen and carbon dioxide in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs.

What are the risks of each ventilator mode?

The three modes in this study (volume control, pressure control, and adaptive pressure control) are used every day across the world. As far as we know today, both all 3 modes are equally safe and effective. However, it is possible that using volume control could reduce the risk of large breaths that injure the lungs, while using pressure control could reduce the risk of high pressure that injure the lungs, and using adaptive pressure control could reduce the risk of both large breaths and high pressures. The goal of the MODEM trial is to determine if mode affects those risks and affects how patients recover from their illness to get off the breathing machine faster.

Who is eligible for the MODEM study?

Adults who are receiving treatment in an intensive care unit (ICU) who are receiving support from a breathing machine through a breathing tube. Patients can only participate if they are in an ICU at a hospital participating in the study. They cannot volunteer at any other time.

This work is supported through a National Heart Lung and Blood Institute (NHLBI) Project Number (K23HL175246).

Current Trials

Posted on

ANGLE

May 2026
Posted on by briserv

What we need to learn

To safely connect a patient to a breathing machine, doctors place a breathing tube through the mouth, past the vocal cords, and into the windpipe. To do this, they use a tool called a “video laryngoscope” to see the vocal cords and guide the breathing tube into place.

There are two common types of “video laryngoscopes”:

  • Hyperangulated: a more curved design that makes it easy to see the vocal cords but creates a less direct path for placement of the breathing tube.
  • Standard geometry: a less curved design that requires more manipulation (movement of the jaw) to see the vocal cords but creates a more direct path for placement of the breathing tube.

What we are doing

This research study is called the “Hyperangulated versus Standard Geometry Laryngoscope Blade Trial” (ANGLE). The goal of the study is to learn whether a hyperangulated or standard video device is better, and for which types of patients, for placing the breathing tube safely on the first try. Placing the breathing tube on the first try is good because the quicker the breathing tube is placed, the lower the chances that the patient experiences low oxygen levels, low blood pressure levels, or other complications.

This research will take place in emergency departments (EDs) and intensive care units (ICUs), which care for all different types of patients.

Participating in this study will not impact the quality of care patients receive. For each patient:

  • If doctors think the hyperangulated device is best for a patient, they will use that device, and the patient will not take part in the study.
  • If doctors think the standard device is best for a patient, they will use that device, and the patient will not take part in the study.
  • If the doctors think both devices are equally safe and effective for the patient, the patient will be enrolled in the ANGLE study and which type of video laryngoscope is used to place the breathing tube will be randomly chosen by the ANGLE study.

The study team will confidentially review the patient’s medical record as part of the research.

Questions?

If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Stephanie DeMasi at stephanie.demasi@vumc.org or (615)-208-6139. If you have questions about your rights as a research participant, or concerns or complaints about the research, you may also contact the Vanderbilt Human Research Protections Program at (615)- 322-2918.

FAQs

What is a breathing machine? 

Some seriously ill patients in the hospital need help to breathe. In this situation, a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs. The procedure for inserting a tube into the mouth to reach the lungs is called “intubation”. 

What are the risks of each video device type? 

During intubation in the ED or ICU patients are at risk for problems like low oxygen levels, low blood pressure, heart rhythm problems, or even death. All of these risks are present no matter which type of video laryngoscope is used.

Both hyperangulated and standard video laryngoscopes are used to place breathing tubes every day across the world. As far as we know today, both are equally safe and effective. It is possible that this study could find that the curved (hyperangulated) device or the less curved (standard) device makes it easier to place the breathing tube and improves outcomes. The goal of the ANGLE study is to determine if video device type affects these risks.

Who is eligible for the ANGLE study? 

Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time.

  • Adults who are receiving treatment in a participating emergency room or intensive care unit (ICU) whose doctors have determined that they need a breathing tube may be eligible for this study.
  • Patients are eligible only if their doctors and nurses think that using either a hyperangulated or standard video laryngoscope to place a breathing tube would be consistent with optimal care for them.
  • Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time.

Current Trials

Posted on

INSPIRE

Feb 2026
Posted on by briserv

Why the INSPIRE Study is Needed:

Each year millions of seriously ill adults need life-saving treatment with a breathing machine. To place someone on a breathing machine, doctors must place a breathing tube through the patient’s mouth and into the windpipe (a procedure known as “intubation”).  When sick patients are placed on a breathing machine in an emergency department or intensive care unit (ICU), doctors commonly give patients a medicine to make them sleepy and comfortable (a “sedative”) while the breathing tube is being placed.  Many doctors also give a second medication to temporarily immobilize the patient’s muscles to make it easier to place the breathing tube (a “neuromuscular blocker”).  Which approach is best is uncertain.

Each approach has potential benefits and risks. Giving only a sedative may prevent low oxygen levels by allowing patients to continue breathing on their own during the procedure, but it might make it harder for doctors to place the breathing tube.  Giving both a sedative and a neuromuscular blocker might make it easier for doctors to place the breathing tube, but it might lead some patients to feel awake but unable to move during or shortly after the procedure.

Patients who need a breathing machine are often seriously ill.  Understanding which of these two approaches results in the best outcomes for patients is important.

What we are doing

We are doing a research study called “INtubation with Sedation Only to Preserve Independent Respiratory Effort” (INSPIRE).  The goal of the study is to learn whether, for patients being placed on a breathing machine in an emergency room or ICU, using only a sedative or using both a sedative and a neuromuscular blocker is best for patients.

During the study, if doctors and nurses feel that using only a sedative would be best for a patient, they use only a sedative. If they feel that using both a sedative and a neuromuscular blocker would be best for a patient, they use both a sedative and neuromuscular blocker. If doctors and nurses do not have a feeling about which approach would be best for a patient, the patient is enrolled in the INSPIRE trial. For patients in the INSPIRE trial, a computer randomly assigns the patient either to receive only a sedative or to receive both a sedative and a neuromuscular blocker.  This means every patient has a fair and equal chance of receiving either approach.

Consent for Emergency Care

Placing seriously ill adults on a breathing machine is an emergency procedure. There is often no time for doctors to discuss the risks and benefits of the procedure or the risk and benefits of the medications that will be used. Patients are often unconscious or too sick to make decisions. So, doctors go ahead with life-saving care without the patient’s okay (“consent”).

Consent for Research during Emergency Care

For these same reasons, it may not be possible to get patients’ consent for a study comparing use of only a sedative to use of both a sedative and a neuromuscular blocker. But important research to improve care for life-threatening conditions can sometimes be done without getting patients’ consent ahead of time. This is through a process called “Exception from Informed Consent Requirements for Emergency Research (EFIC).” Studies done with EFIC are designed with input from patients, families, and community members and overseen by an independent ethics committee.

​If you were to be seriously ill and receiving a breathing tube in an emergency department or intensive care unit taking part in the INSPIRE study and your doctors determined that it would be safe to perform the procedure with either a sedative alone or both a sedative and neuromuscular blocker, you could be enrolled in the INSPIRE trial. You would receive whichever approach the computer randomly assigned to you. There might not be time to ask if you would like to take part in the study beforehand. But an INSPIRE study team member would come to you (or your family) after the procedure. They would tell you about the study, ask for your consent to continue participating in the study going forward, and provide information about how to stop taking part at any time, if you so choose. 

Participating Sites

  • Vanderbilt Health

Frequently Asked Questions

Who is eligible?

Adults who are receiving treatment in an emergency room or ICU whose doctors have determined that they need a breathing tube may be eligible for this study. Patients are only eligible if their doctors and nurses think that either strategy would be safe and effective.  Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time.

What are the risks of intubation with only a sedative?

Giving only a sedative may prevent low oxygen levels by allowing patients to continue breathing on their own during the procedure, but it might make it harder for doctors to place the breathing tub

What are the risks of intubation with a sedative and a neuromuscular blocker?

Giving both a sedative and a neuromuscular blocker might make it easier for doctors to place the breathing tube, but it might lead some patients to feel awake but unable to move during or shortly after the procedure.

Why are you sharing information about this trial with the community?

The goal of the INSPIRE trial is to produce information that helps patients, families, doctors, and nurses choose the approach that results in the best outcomes for patients receiving a breathing tube in the emergency room or ICU. Making sure that patients, families, and community members know about the study and its findings is important to achieving this goal. For that reason, patients, family members, and community members helped design the study, are helping to lead it, and will help us share the results of the study when it is completed.  The results will be shared with the patients who participated in the study and with the community. We want people to be aware of the study, have an opportunity to ask questions, and have their voices heard.

How can I provide more feedback about the study?

We are interested in the community’s feedback about the study. Below is a link to a survey that asks specific questions related to the study: https://redcap.vumc.org/surveys/?s=J9KA7333PDW3RMKW

Current Trials

Posted on

BREATHE

Jul 2025
Posted on by briserv

What we need to learn

To safely connect a patient to a breathing machine, doctors place a breathing tube through the mouth and between the vocal cords (intubation). A breathing tube can put pressure on a patient’s voice box and cause an ulcer (similar to how shoes can cause blisters on feet). If an ulcer develops, it can cause long-term problems with breathing, speaking, and swallowing even after the tube is taken out. Some breathing tubes are smaller and some are larger.  Using smaller breathing tubes may prevent these long-term problems with breathing, speaking, and swallowing, whereas using larger breathing tubes may help patients get off of the breathing machine faster.

What we are doing

This research study is called the “Tube Size Randomized Trial during Emergency Tracheal Intubation” (BREATHE) and is funded by the Patient Centered Outcomes Research Institute (PCORI). The goal of the study is to learn whether smaller or larger breathing tubes (personalized for a patient’s height) are better for getting patients through their critical illness and preventing long-term problems with breathing, speaking, and swallowing.

Participating in this study will not impact the quality of care patients receive. For each patient:

  • When the doctors feel a smaller tube would be best for a patient, they will use a smaller breathing tube, and the patient does not take part in the study.
  • When the doctors feel that a larger breathing tube would be best for a patient, they will use a larger breathing tube, and the patient does not take part in the study.
  • When the doctors think that both a smaller and larger breathing tube would be equally safe and effective for the patient, the patient will be enrolled in the BREATHE study and the breathing tube will be randomly chosen by the BREATHE study. If, at any time, the patient’s condition changes, doctors can change the breathing tube for whatever size they think is needed.

The study team will:

  • confidentially review the patient’s medical record
  • meet with the patient after the breathing tube is removed
  • explain the study and ask for permission to contact the patient 6 months after breathing tube placement
  • ask the patient at 6 months after breathing tube placement about his or her breathing, speaking, and swallowing

Questions

If you have any questions or concerns about this study, you may contact the Principal
Investigator, Dr. Jonathan Casey at Jonathan.d.casey@vumc.org or (615) 208-6139. If
you have questions about your rights as a research participant, or concerns or
complaints about the research, you may also contact the Vanderbilt Human Research
Protections Program at (615)- 322-2918.

Participating Sites

  • Vanderbilt Health
  • Denver Health
  • Hennepin Healthcare
  • University of Alabama at Birmingham
  • University of Colorado at Denver
  • University of Washington
  • Wake Forest Atrium Health

Frequently Asked Questions

What is a breathing machine? 

Some seriously ill patients in the hospital need help to breathe. In this situation a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs. The procedure for inserting a tube into the mouth to reach the lungs is called “intubation”. 

What are the risks of each size tube? 

Both smaller and larger breath tubes are used every day across the world. As far as we know today, both smaller and larger breathing tubes are equally safe and effective. However, it is possible that smaller breathing tubes could reduce the risk of injury to the voice box while larger breathing tubes help get patients through their illness and off the breathing machine faster. The goal of the BREATHE study is to determine if breathing tube size affects any of these risks.

Who is eligible for the BREATHE study? 

Adults who are receiving treatment in a participating emergency room or intensive care unit (ICU) whose doctors have determined that they need a breathing tube may be eligible for this study. Patients are eligible only if their doctors and nurses think that using either a smaller or larger breathing tube would be consistent with optimal care for them. Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time. 

This work is supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (BPS 2024C1-37478).

Patient Partners

Patricia Wilder

has experienced both emergency and extended intubation as the result of her being shot as a young adult. After weeks of being intubated and having a tracheostomy, she had to re-learn to swallow properly and to speak normally. “Over the past 50+ years, I’ve had countless surgeries/recoveries resulting from the original injury. Advising on this project is a way for me to further patient-centered care in emergency settings and planned procedures based on lessons I have learned. I’m grateful for the opportunity.” Since April 2022, Ms. Wilder served on the Patient Engagement Panel for the ADVANCE Collaborative, a Clinical Research Network led by OCHIN. Also, she has been an active advisor on AA-CONVENE, a research study using Artificial Intelligence to identify exposure to firearm violence in EHR clinical notes. Ms. Wilder is the Patient Stakeholder for the University of Washington.

April-Lynn-Stovern

is a COVID intubation survivor who was intubated for 19 days. After 42 days of combined hospitalization and rehab, she experienced brain fog and other symptoms of long-COVID. April is passionate about supporting research that is focused on improving outcomes for patients in the critical care space and hopes to use her patient experience and healthcare journey to provide support and guidance to research teams as they work to establish best practices. “I believe this research is important because it directly impacts millions of people who rely on the ventilator for survival and my hope is this will reduce symptoms and complications with prolonged intubation. Over 3 ½ years later I still feel the effects of my intubation.” Her background in logistics and customer service also provides expertise to help guide patient-facing study components. Mrs. Stovern serves as the Patient Stakeholder for the University of Minnesota Hennepin.

Kelly Harden

brings decades of experience as both a Nurse Practitioner and educator serving as the Dean of a College of Nursing. Her personal journey as a patient and two-time transplant survivor, however, provides incredible insight into the challenges of navigating a complex healthcare system. As a committed Advisory Council member, she provides recommendations to ensure that patient facing information is accessible and that the team considers patient and caregiver perspectives. “Being a patient representative on a research study team is an honor and a responsibility. I have the privilege to bring real voices into scientific discovery and to ensure that the human side of research is never forgotten.” Ms. Harden’s personal and professional backgrounds are uniquely well suited to provide patient-centered feedback to enhance clinical care and research. Ms. Harden serves as the Patient Stakeholder for Vanderbilt Health.

Catherine Anderson

was diagnosed with airway stenosis in 2004 after two years of misdiagnosis, and her journey has included numerous surgeries and treatments, including a major airway reconstruction. She is the Founder and CEO of Living with Idiopathic Subglottic Stenosis community, now the largest global support group for airway stenosis patients. A frequent conference presenter and guest speaker, she is also an avid patient advocate with multiple publications in the clinical trial space. She brings extensive experience in patient recruitment, questionnaire design, and data interpretation centering the patient and caregiver experience. Catherine serves as a consultant to the North American Airway Collaborative at Vanderbilt Health and is professionally trained in market research and works with doctors to conduct research into iSGS and its treatments. Ms. Anderson serves as an organizational representative and Patient Stakeholder, representing the larger ISS patient community.

Eileen Rubin

co-founder of the ARDS Foundation, has served as President and CEO for over two decades. An attorney by profession, Ms. Rubin experienced a life-altering diagnosis in her early 30’s that resulted in a lengthy ICU stay and long road to recovery. Today, she a well- known advocate for patients and their families serving in a variety of roles to help educate medical professionals and to improve and inform research. Ms. Rubin stresses, “Including the patient and family perspective is critical in medical research to ensure studies are designed from beginning to end with the patient in mind and with objectives focused on concerns, issues and endpoints of importance not only to advance medical research but also to include priorities of patients.“ She has served in an advisory capacity for numerous organizations including the American College of Chest Physicians, the Society of Critical Care Medicine and the American Thoracic Society. She was also the lead investigator for a PCORI Pipeline to Proposal Award. Ms. Rubin is an organizational representative and Patient Stakeholder providing insight on patient centeredness and dissemination priorities.

Sherman Transou

was an active business owner but in 2015 his life was changed when he learned that a virus was attacking his heart. Five months later he joined the growing community of transplant recipients and has embraced this opportunity to inspire and educate others in his community. With over 30 years of experience in leadership, client retention, and customer service, Sherman understands the urgency of fostering strong relationships and uses his background to prioritize the patient-centeredness of research. In addition to serving on the Board of Directors for HonorBridge, he is an active advocate, speaker and leadership coach. Mr. Transou uses his experience as a patient to help research teams effectively connect with patients and their families. Mr. Transou is the Patient Stakeholder for the Coordinating Site at Atrium Health Wake Forest Baptist.

Barbara Gould

is a COVID intubation and liver transplant survivor and has personal experience with post ICU syndrome and PTSD. As a retired social worker, Ms. Gould understands the importance of patients’ physical and mental health and has used her experience to platform the needs of patients and families. She shared, “I strongly believe that medical research saves lives and that patient representation in that process is essential.” Ms. Gould has spoken with the media about her hospitalization with COVID to raise awareness and most recently was the patient representative for the PCCRG group at the ATS 2025 International Conference. Ms. Gould serves as the Patient Investigator for the University of Colorado Anschutz and the University of Colorado Denver.

Jasmine McIntosh

is a young adult cancer survivor who is an active advocate in the community. She is passionate about health inequities and supports research that is working to improve outcomes for all patients. Her background in systems and technology is an asset to clinical trials. “I believe clinical trial research is important because for me personally, as a two-time cancer survivor with a rare gene, research has allowed me to be on the receiving end of innovative care. I am grateful for that access as not everyone has that same opportunity. Research helps to make it more accessible and to continue the work toward health equity.” Ms. McIntosh is the Patient Stakeholder for the University of Alabama, Birmingham, providing guidance on community consultations and patient facing materials.

We want to know what you think about the BREATHE study

We welcome feedback and questions from the community about research like this. If you have comments or questions please contact Dr. Jonathan Casey at Jonathan.d.casey@vumc.org or (615) 208-6139

Current Trials

Posted on

WAVE

May 2025
Posted on by briserv

Doctors and scientists started the “Waveform capnography and colorimetric carbon dioxide detection during tracheal intubation of critically ill adults (WAVE)” study in April of 2025. This website provides information about the WAVE study.
 
The goal of the WAVE study is to determine whether one of the two methods that doctors commonly use to verify that a recently-placed breathing tube is correctly located in the windpipe (trachea) is best.

Why the WAVE Study is Needed:

When doctors care for some patients who are very sick, a plastic breathing tube is inserted through the mouth and into the windpipe (called the trachea). A breathing machine (called a ventilator) is then connected to this plastic tube to help the patient breathe.

After the breathing tube is inserted, doctors must know for sure that it is in the correct place (the windpipe). If the breathing tube was accidentally inserted somewhere else, such as the passage that carries food to the stomach (the esophagus), air won’t reach the lungs, and the patient will get worse.

Doctors watch the breathing tube during placement to be sure that it correctly enters the windpipe. To confirm that it is inserted correctly, doctors use one of two simple tests at the bedside every time a breathing tube is inserted. Both tests work in a similar way—by looking for carbon dioxide in the breathing tube. Carbon dioxide is a substance that leaves the body only through your breath when you exhale so if carbon dioxide is detected coming from the breathing tube, the doctor knows it is in the correct place.

  • Waveform test: One carbon dioxide test in widespread use senses the amount of carbon dioxide exhaled every breath and displays that information for the doctor as a graph (also known as a waveform) on a digital monitor.
  • Color test: The other carbon dioxide test uses a special color-changing paper to show the doctor that carbon dioxide is present in each breath from the breathing tube. Both tests are approved by the U.S. Food and Drug Administration (FDA).

Both work and are used for millions of patients each year, but the study is trying to figure out if one is best.

What we are doing

Doctors and nurses are doing a research study to try and learn which carbon dioxide test is best for our patients who are very sick and need a breathing tube inserted. The study is named the WAVE Trial.

Normally a doctor would use either the waveform test or the color test right after the breathing tube is inserted to be sure it is in the correct location. In this study:

  • Doctors will use both tests at the exact same time
  • During and right after the breathing tube insertion, detailed information is collected on the breathing tube procedure, patient vital signs, and whether the two tests showed doctors that the breathing tube was in the correct location.
  • Researchers will collect more information about the patient and the breathing tube procedure from the medical record.
Photograph of both color and waveform tests in use on a patient with a breathing tube in the Emergency Department, as is done during the WAVE study.

The doctors and nurses will care for all patients as they normally would, including using the information from both carbon dioxide tests to deliver the best care. Participating in this study will not change the quality of care that patients receive.


Consent for Emergency Care

Placing seriously ill adults on a breathing machine is an emergency procedure. There is often no time for doctors to discuss the risks and benefits of the procedure. Patients are often unconscious or too sick to make decisions. So, doctors go ahead with life-saving care without the patient’s okay (consent).

Consent for Research during Emergency Care

For these same reasons, doctors may enroll patients in the WAVE Trial and collect information from both carbon dioxide tests after breathing tube insertion without getting the patient’s okay (consent). Important research to find the best emergency care, like the WAVE study, can sometimes be done without getting patients’ okay (consent) ahead of time through a process called “Waiver of informed consent”. Studies done with waiver of informed consent are reviewed by researchers, doctors, and an independent ethics committee.

Participating Sites

  • Albany Medical Health System
  • Atrium Health Wake Forest Baptist Medical Center
  • Duke University Medical Center
  • Hennepin County Medical Center
  • Lahey Hospital & Medical Center
  • Ohio State University Medical Center
  • Oregon Health & Science University
  • Regions Hospital
  • Rush University System for Health

Frequently Asked Questions

What is a breathing machine?

Some seriously ill patients in the hospital need help to breathe. In this situation a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs. The procedure for inserting a tube into the mouth to reach the lungs is called “intubation”.

Who is eligible for the WAVE study?

Adults who are receiving treatment in an emergency room or intensive care unit (ICU) whose doctors have determined that they need a breathing tube may be eligible for this study. Patients are eligible only if their doctors and nurses think that using both the color and waveform tests after intubation is safe for the patient. Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time.

What is the difference between the waveform device and the colorimetry device?

Both are FDA approved devices that are used every day by doctors to make sure the breathing tube is correctly positioned in the windpipe.

  • The waveform device checks the air that passes through the breathing tube so that it can measure how much carbon dioxide (CO2) is present. This amount of CO2 is then shown on a medical monitor as a graph of CO2 in the air going in and out of the breathing tube over time. The doctor can look at the graph and see the CO2 levels rise as air leaves the lungs and fall as fresh air enters the lungs.
  • The colorimetry device connects to the breathing tube and has a small piece of litmus paper that changes color when the level of CO2 changes. When air leaves the lungs the paper turns yellow, and when fresh air enters the lungs the paper turns purple.

What are the risks of each test?

There are no known risks to either method of confirming the location of the tube. Both are used every day across the world. Normally your doctor would use either the waveform method or the colorimetry method to check tube location. In this study, your doctor used the information from both methods to confirm the tube is in the correct location.

Why are you sharing information about this trial with the community?

The goal of the WAVE trial is to produce information that helps patients, families, and doctors  choose the best test to check breathing tube placement so that patients can receive the best care possible. Making sure that patients, families, and community members know about the study and its findings is important to achieving this goal.

We want to know what you think about the WAVE Trial

We welcome feedback and questions from the community about research like this. If you have comments or questions please contact Dr. Brian Driver at brian.driver@hcmed.org or call him at 612-873-7448.