Patients in the intensive care unit who require treatment with a breathing machine may develop serious problems with blood pressure or heart rhythm while the breathing tube is being placed. To learn whether problems with blood pressure or heart rhythms could be prevented by giving patients fluid through an IV, we led a research study called PREPARE. The PREPARE trial included 337 patients from 8 intensive care units and one emergency department. The trial found that giving fluid through an IV did not prevent seriously low blood pressure, but that the fluid might have been helpful for some patients receiving oxygen through a mask before the procedure (called “non-invasive ventilation”). These results suggested that IV fluid might prevent low blood pressure among patients on non-invasive ventilation prior to placement of a breathing tube And were the basis for the PREPAREII trial (described above).
Background: Tracheal intubation is common in the care of critically ill adults and is frequently complicated by hypotension, cardiac arrest, or death. We aimed to evaluate administration of an intravenous fluid bolus to prevent cardiovascular collapse during intubation of critically ill adults.
Methods: We did a pragmatic, multicentre, unblinded, randomised trial in nine sites (eight ICUs and one emergency department) around the USA. Critically ill adults (≥18 years) undergoing tracheal intubation were randomly assigned (1:1, block sizes of 2, 4, and 6, stratified by study site) to either an intravenous infusion of 500 mL of crystalloid solution or no fluid bolus. The primary outcome, assessed in the intention-to-treat population, was cardiovascular collapse, defined as a new systolic blood pressure <65 mm Hg; new or increased vasopressor receipt between induction and 2 min after tracheal intubation; or cardiac arrest or death within 1 h of tracheal intubation. Adverse events were assessed in the as-treated population. This trial, which is now complete, is registered with ClinicalTrials.gov, number NCT03026777.
Findings: Patients were enrolled from Feb 6, 2017, to Jan 9, 2018, when the data and safety monitoring board stopped the trial on the basis of futility. By trial termination, 337 (63%) of 537 screened adults had been randomly assigned. Cardiovascular collapse occurred in 33 (20%) of 168 patients in the fluid bolus group compared with 31 (18%) of 169 patients in the no fluid bolus group (absolute difference 1·3% [95% CI -7·1% to 9·7%]; p=0·76). The individual components of the cardiovascular collapse composite outcome did not differ between groups (new systolic blood pressure <65 mm Hg 11 [7%] in the bolus group vs ten [6%] in the no-bolus group, new or increased vasopressor 32 [19%] vs 31 [18%], cardiac arrest within 1 h seven [4%] vs two [1%], death within 1 h of intubation two [1%] vs one [1%]). In-hospital mortality was not significantly different in the fluid bolus group (48 [29%]) compared with no fluid bolus (59 [35%]).
Interpretation: Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial.
Funding: US National Institutes of Health.
Manuscript Title: “Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial.”
When a patient needs a breathing machine, a breathing tube is placed through the mouth and into the windpipe. Difficulty placing the breathing tube may cause serious problems with low oxygen levels, low blood pressure, or injury to the windpipe or lungs. To place the breathing tube, doctors use a tool called a “scope” to see past the tongue for placement of the breathing tube in the windpipe. Two types of “scope” are commonly used. One is called a “video laryngoscope” and another is called a “direct laryngoscope”. The DEVICE trial compared use of a video laryngoscope with use of a direct laryngoscope in 1,417 patients in 7 emergency departments and 10 intensive care units across the United States. The study showed that use of a video laryngoscope increased the probability of successful breathing tube placement on the first attempt.
Importance
For critically ill adults undergoing emergency tracheal intubation, failure to intubate the trachea on the first attempt occurs in up to 20% of cases and is associated with severe hypoxemia and cardiac arrest. Before the DEVICE trial it remained unknown whether use of a video laryngoscope or use of a direct laryngoscopes was better for patients.’
Objective
To compare the effect of use of a video laryngoscope versus a direct laryngoscope on successful intubation on the first attempt among critically ill adults undergoing tracheal intubation in the acute care setting. Design, setting, and participants: The DirEct Versus Video LaryngosCopE (DEVICE) trial was a multi-center, parallel-group, non-blinded, randomized clinical trial among 1,417 critically ill adults undergoing orotracheal intubation in 7 emergency departments and 10 ICUs in 11 medical centers across the United States.
Interventions
Patients were randomly assigned to the video laryngoscope group (n =705) or the direct laryngoscope group (n = 712).
Main outcomes and measures
The primary outcome was successful intubation on the first attempt. The secondary outcome was the incidence of severe complications.
Results
Among 1417 patients who were included in the final analysis, successful intubation on the first attempt occurred in 600 patients (85.1%) in the video-laryngoscope group and in 504 patients (70.8%) in the direct-laryngoscope group (absolute risk difference, 14.3 percentage points; 95% CI, 9.9 to 18.7; P<0.001). A total of 151 patients (21.4%) in the video-laryngoscope group and 149 patients (20.9%) in the direct- laryngoscope group had a severe complication during intubation (absolute risk difference,
0.5 percentage points; 95% CI, −3.9 to 4.9). Safety outcomes, including esophageal intubation, injury to the teeth, and aspiration, were similar in the two groups.
Conclusions and relevance: Among critically ill adults undergoing tracheal intubation in an emergency department or ICU, the use of a video laryngoscope resulted in a higher incidence of successful intubation on the first attempt than the use of a direct laryngoscope.
ClinicalTrials.gov Identifier: NCT05239195 Manuscript Title: Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. Journal: New England Journal of Medicine PMID: 37326325
More information
This study is called “Direct Versus Video Laryngoscope (DEVICE)” and is funded by the U.S. Department of Defense. Our goal is to learn whether a “scope” with a video screen or a “scope” without a video screen is better for placing a breathing tube and preventing problems with oxygen levels and blood pressure. Participating in this study will not impact the quality of care patients receive. For each patient:
When the doctors feel a “scope” with a video screen would be best for a patient, the team will use a “scope” with a video screen.
When the doctors feel that a “scope” without a video screen would be best for a patient, the team will use a “scope” without a video screen.
When the doctors do not have a preference, the patient will be assessed against the inclusion / exclusion criteria and when appropriate, enrolled in DEVICE. Once the patient is enrolled in DEVICE, the type of “scope” is assigned randomly, meaning that every patient will have a fair and equal chance of getting either type of “scope.”
Questions
If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Jonathan Casey. He will be glad to answer any study-related questions. Dr. Casey’s phone number is (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; Denver Health; Ochsner; University of Washington; Duke University; University of Alabama, Birmingham; Baylor, Scott &White; University of Colorado, Denver; Hennepin County Medical Center; Wake Forest; Brooke Army Medical Center, Beth Israel Deaconess,
Trial Update
On November 17th 2022, the investigators were notified by the Data and Safety Monitoring Board that the DEVICE trial had met the prespecified stopping criteria at the time of the single interim analysis. Enrollment in the trial was stopped and investigators and clinicians at participating sites were notified.
Trial Update
On November 17th 2022, the investigators were notified by the Data and Safety Monitoring Board that the DEVICE trial had met the prespecified stopping criteria at the time of the single interim analysis. Enrollment in the trial was stopped and investigators and clinicians at participating sites were notified.
Doctors and scientists started the “Randomized Trial of Sedative Choice for Intubation (RSI)” in April of 2022. This website provides information about the RSI study.
The goal of the RSI trial is to learn which of two drugs (“ketamine” or “etomidate”) is best for patients receiving a breathing tube – overall and for specific groups of patients with medical problems like heart disease or severe infection.
Why the RSI Study is Needed:
Each year millions of seriously ill adults need life-saving treatment with a breathing machine. To safely place someone on a breathing machine (a procedure known as “intubation”), doctors give a drug to make the patient sleepy (known as a “sedative”). The two “sedative” drugs given most often to seriously ill patients receiving a breathing tube in the United States are ketamine and etomidate. Both drugs are approved by the United States Food and Drug Administration (FDA).
Both are considered safe and effective. Both are given by doctors all the time. But it is not known which drug is best. Each drug may have benefits or risks. Ketamine may have a temporary negative effect on heart function in some patients. Etomidate may have a temporary negative effect on the hormones that help keep blood pressure normal. Early studies suggested that patients did equally well with the two drugs. Knowing for certain whether the two drugs really are the same for patients, or if one is better, could save many patients lives in the future.
What we are doing
Doctors and scientists are doing the “Randomized Trial of Sedative Choice for Intubation (RSI)” study to learn for certain whether ketamine and etomidate are the same for patients being placed on a breathing machine, or if one is better for preventing serious problems with blood pressure, oxygen levels, or heart function.
For patients being placed on a breathing machine in an emergency department or an intensive care unit that is part of the RSI study:
When the doctors feel ketamine would be best for a patient, the doctors give the patient ketamine.
When the doctors feel that etomidate would be best for a patient, the doctors give the patient etomidate.
When the doctors do not have a preference, the patient participates in the RSI study and assigned either ketamine or etomidate randomly. This means every patient has a fair and equal chance of getting either drug.
Remember: Both drugs are commonly used to place patients on breathing machines. Both are approved by the FDA for this use. Both are deemed safe and effective. Only when doctors do not have a preference does the RSI study choose the drug – and even then the doctors can always choose to use another drug to ensure the best care for the patient. During the placement of a breathing tube doctors and nurses are standing with the patient, closely watching to keep them safe, and preventing and treating possible problems.
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 of the drug 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 for patients to give consent to take part in the RSI study. Important research to find the best emergency care, like the RSI study, can sometimes be done without getting patients’ okay (consent) ahead of time through a process called “Exception from Informed Consent” (EFIC). Studies done with EFIC are designed with input from patients, families, and community members and overseen by the FDA (FDA 21 CFR 50.24 ) and an independent ethics committee.
If you are seriously ill and are being placed on a breathing machine in an emergency department or intensive care unit taking part in the RSI study, your doctors feel that using either ketamine or etomidate would be safe and effective for you, AND there is not enough time to ask you or your family if you would like to take part in the RSI study:
You would be enrolled in the study.
You would receive whichever of the two drugs is randomly chosen by the study.
A study team member would come to you (or your family) after the procedure and give you information about the study, answer your questions, and let you know how you could choose to stop taking part in the study.
Participating Sites
Vanderbilt University Medical Center
University of Colorado, Anschutz
Denver Health Medical Center
Wake Forest Atrium Health
Hennepin County Medical Center
University of Alabama, Birmingham
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 help the lungs. 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 RSI 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 either of the study medications would be safe and effective for the patient. Patients are not eligible if they are allergic to one of the study medications. 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 ketamine and etomidate? You can probably imagine how hard it would be to have a tube put in your throat if you were awake. Ketamine and etomidate are both medicines that doctors give to make patients sleepy (sedate them) during the placement of a breathing tube. The medicines differ in how they make patients sleepy. Ketamine makes patients sleepy through one signal in the brain and etomidate uses a different signal in the brain. The medicines also differ in their possible side effects, as described below. Both medicines have been used during placement of a breathing tube every day in clinical care for decades.
What are the side effects of each medication? When ketamine is used to sedate patients for the placement of a breathing tube, the most common side effects are altered mental status and nausea or vomiting. Uncommon but more severe potential side effects include serious problems with heart rate and blood pressure, allergic reactions, and buildup of pressure around the brain.
When etomidate is used to sedate patients for the placement of a breathing tube, the most common side effects are a sudden spasm of the muscles, low levels of stress hormones, and nausea or vomiting. Uncommon but more severe potential side effects include serious problems with heart rate and blood pressure, allergic reactions, and spasm of the vocal cord.
Why would a doctor choose one medication over the other? For most patients, doctors do not have a reason to think that one medication would be better than the other. Rarely, a patient has an illness for which doctors know that one medicine would be better than the other. For example, for a patient with very high blood pressure, doctors may choose to use etomidate rather than ketamine because ketamine may increase blood pressure. When doctors do not have a reason to think that one medication would be better than the other, they may choose the medication that is most immediately available in their hospital, most common in their region of the country, or most often used by other doctors in their specialty. The purpose of the RSI trial is to provide information to doctors to ensure they know which medication is best for which patient.
Why did you choose to study ketamine versus etomidate? Each year millions of patients undergo breathing tube placement in an emergency room or ICU. Because doctors believe that ketamine and etomidate are equally effective for breathing tube placement, some use ketamine, and some use etomidate. However, breathing tube placement can be dangerous, especially for seriously ill patients. It is important to know if ketamine or etomidate improves outcomes for some patients or all patients during placement of a breathing tube. The only way to figure out if ketamine or etomidate is better for some or all patients is to do a study like this one. We hope this study gives sick patients a better chance of surviving their illness and improves their long-term mental health.
When will you tell patients which medication they received? The research team tells patients (and their families) which medicine the patient received shortly after the breathing tube is placed. In the RSI study, patients, families, doctors, nurses, and researchers all know which medicine the patients received throughout the study.
How are patients randomized to receive either ketamine or etomidate? Research studies often use two groups of participants to compare treatment options. Because people are different in many ways, those groups need to have a similar mix of people. This is true for things like age and background. If the groups are too different, the research team might not be able to learn from the study. The best way to get a similar mix is to put patients in each group randomly. This is called randomization. Randomization means that each patient in the study has a fair and equal chance of receiving either medication. If a patient’s doctors and nurses think that either ketamine or etomidate would be safe and effective for the patient, the doctor lets the study decide which medication the patient will get.
Why are you sharing information about this trial with the community? The goal of the RSI trial is to produce information that helps patients, families, doctors, and nurses choose the medicine that produces 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-with patients who participated and with the community. We want people to be aware of the study, have an opportunity to ask questions and have their voices heard.
We want to know what you think about the RSI Trial
We want feedback from the community about research like this. Please share your opinions at: https://redcap.link/rsitrial
If you do not wish to participate in this study
If you would not want to participate in this research study can if you became severely ill and needed treatment with a breathing machine, contact us at Jonathan.D.Casey@vumc.org or 615-208-6139. We will send you a bracelet you can wear that will inform your medical team of your decision even if you are unconscious.
When patients need a breathing machine, a breathing tube is placed through the mouth and into the windpipe. During placement of the breathing tube, patients may experience serious problems with low oxygen levels or low blood pressure. Doctors give oxygen through a mask before the procedure to prevent low oxygen levels. Two types of oxygen mask are commonly used. Both provide oxygen. One also provides pressure to open the lungs. Both types of masks are FDA approved and both are frequently used in emergency department (ED) and intensive care unit (ICU). The purpose of this study is to determine if one type of mask is better than the other.
What we are doing
This study is called “Pragmatic Trial Examining Oxygenation prior to Intubation (PREOXI),” and is funded by the U.S. Department of Defense. Our goal is to learn whether an oxygen mask with pressure or an oxygen mask without pressure is better for preventing problems with low oxygen levels. Participating in this study will not impact the quality of care patients receive. For each patient:
When the doctors feel an oxygen mask with pressure would be best for a patient, the team will use an oxygen mask with pressure.
When the doctors feel that oxygen mask without pressure would be best for a patient, the team will use an oxygen mask without pressure.
When the doctors do not have a preference, the patient will be assessed against the inclusion/exclusion criteria and when appropriate, enrolled in PREOXI. Once the patient is enrolled in PREOXI, the type of mask is assigned randomly. This means every patient will have a fair and equal chance of getting either type of mask.
Questions
If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Jonathan Casey. He will be glad to answer any study-related questions. Dr. Casey’s phone number is (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; University of Alabama, Birmingham; Baylor, Scott &White; University of Colorado, Denver; Hennepin County Medical Center; Wake Forest; Brooke Army Medical Center; Lahey Health; Oregon Health & Sciences University; University of Iowa; Ohio State; University of Wisconsin; Montefiore Medical Center; Our Lady of the Lake Medical Center
Drs Brian Driver and Matt Prekker join Rob Mac Sweeney to address some of the questions and comments that arose following the presentation and publication of the BOUGIE trial, comparing the use of a stylet with that of a bougie in emergency intubation.
James Matthew Dargin, MD, 43, of Nashua, died unexpectedly at his home on October 31, 2021. He is the beloved husband of Elizabeth (Caron) Dargin with whom he shared fifteen joyful and blessed years of marriage.
Jim, as he was known to family and friends, was born in Nashua, NH on April 16, 1978. He is the son of John P. and Virginia (Breed) Dargin of Nashua. Jim attended Bishop Guertin High School and then enrolled at Boston University for his Bachelor in Science and in turn a Doctorate in Medicine. He also completed his residency at BU, in Emergency Medicine, at Boston Medical Center, while living in South Boston. Thereafter, he completed a fellowship in Critical Care at the University of Pittsburgh Medical Center before returning to New England to practice. An intensivist in Pulmonary and Critical Care, he served for the past eleven years as a physician at the Lahey Hospital and Medical Center in Burlington, MA. During that time, he held many leadership roles and was awarded multiple awards for his work, in addition to pursuing research, teaching, and mentoring others. He was highly regarded and admired by his colleagues for his deep commitment to his vocation as a physician, both in terms of his care of his patients and his teaching of future physicians.
Well beyond medicine, Jim had a great curiosity and desire for learning, whether from reading, conversation, or exploration. He loved fishing, and also watching Red Sox and Patriots games with friends and family. Absolutely above all else, he cherished time spent with family, especially with his wife and children. He will forever be remembered as the strong and loving family man he was.
In addition to his parents John and Virginia, and his wife Beth, Jim is survived by his two daughters, Paige Marie and Meredith Ann Dargin of Nashua; his brother, John P. Dargin and his wife Kathie of Nashua and his nieces, Brianna and Emma; his sister-in-law, Jennifer Matsis of Milford and his nieces Alexandra and Ashleigh; his aunt, Ann Scalcione and her husband Robert; two uncles, Paul Dargin and Joseph Breed, as well as many cousins and extended family. Jim was predeceased by his in-laws, Normand and Sandra Caron.
Relatives and friends are invited to Jim’s visitation on SUNDAY, November 7th from 3-6 PM at ROCHETTE FUNERAL HOME AND CREMATION SERVICES, 21 Kinsley Street, Nashua. His funeral Mass will be held on MONDAY, November 8th at 10 AM at St. Joseph the Worker Parish, 777 W Hollis Street, Nashua. Interment will follow in St. Louis Cemetery, Nashua. In lieu of flowers, donations may be made in Jim’s name to Beth Israel Lahey Health, please visit
Embedding Pragmatic Trials into Emergency and Critical Care (Matthew W. Semler, MD, MSc; Jonathan D. Casey, MD, MSc)10/29/20210 CommentsSlidesSpeakers Matthew W. Semler, MD, MSc Assistant Professor Vanderbilt University Medical Center Jonathan D. Casey, MD, MSc Assistant Professor Vanderbilt University Medical Center TopicEmbedding Pragmatic Trials into Emergency and Critical CareKeywordsPragmatic clinical trials; Study design; Comparative effectiveness trials; Treatment effect; SMART trial; PreVent trial; Exception from Informed Consent (EFIC) Key PointsEmergency medical clinicians are faced with common decisions in everyday practice with little to no data from randomized clinical trials to help inform their decisions.Four barriers to comparative effectiveness trials in a critical care setting are a brief therapeutic window, patients with multiple co-morbidities, the inability of the patient to consent to research, and analyzing average treatment effect rather than individual treatment effect.The PreVent Trial studied the use of bag-mask ventilation to prevent hypoxemia for patients who had been administered anesthesia in preparation for intubation.Efficient, pragmatic trial procedures that don’t delay treatment enable comparative effectiveness randomized clinical trials to be conducted effectively.After 50 years of debate about bag-mask ventilation during this interval period, the PreVent Trial found that bag-mask ventilation cut the rate of hypoxemia by 50% without affecting aspiration.The SMART Trial was a cluster-randomized, multiple-crossover trial of fluid management that studied patient outcomes when Balanced Crystalloids were used versus Saline solution.The large sample size of over 15,000 patients provided the SMART trial with the power to detect that a balanced crystalloid fluid prevented Major Adverse Kidney Events in 1% of patients compared to Saline solution. /li>Exception from Informed Consent (EFIC), implemented in 1996 allows trials in emergency situations of the condition is life-threatening, existing treatments are unproven or unsatisfactory, and research involves no more than minimal risk.Analyzing Individual Treatment Effects will allow clinical providers to tailor their decisions to their individual patient.Discussion ThemesClinical equipoise poses a challenge for comparative effectiveness trials. Key to getting buy-in from clinician stakeholders is explaining the importance of the research to the pat
NASHVILLE, Tenn. (WTVF) — As the Labor Day weekend concludes, Tennessee continues to see a record-breaking number of people hospitalized with COVID-19.
The latest data from the Tennessee Department of Health reveals there are now 3,597 COVID patients hospitalized across the state. Of those, 1,020 are in ICUs. Before this record influx of COVID patients, the previous record was set back in January.
Recent Stories from newschannel5.com The most recent numbers from Vanderbilt University Medical Center show of the 218 people hospitalized over the last 7 days, 190 were unvaccinated.
“We’re seeing lots of lots people who are unvaccinated who are sick enough to be in the hospital,” said Dr. Todd Rice, a critical care physician at Vanderbilt University Medical Center. “There is some exasperation from nurses. It’s like if you just would have got vaccinated, you likely wouldn’t be here.” Dr. Rice has been treating COVID patients since the beginning of the pandemic. He said 18 months of grueling work has taken a toll on hospital staff.
“These patients are sick,” said Dr. Rice. “They take a ton of resources, energy and time.” Dr. Rice said doctors are also waiting to see if travel and other activities over the Labor Day weekend cause yet another spike in cases.
“Our numbers are high enough right now, I think any increase we see gets buried in the high numbers right now.”
Dr. Rice said the only way to reverse the trend is for more Tennesseans to get vaccinated. He said some unvaccinated patients have expressed regrets they didn’t get the shot, and he hopes others learn from their actions.
“There is no better way to make sure you don’t get COVID and don’t end up in the hospital than to get yourself vaccinated,” said Dr. Rice.
