Patients in the intensive care unit frequently receive IV fluid.  For more than 100 years, two basic types of IV fluid have been available: saline (which contains more chloride than human blood) and balanced crystalloids (which contains about the same amount of chloride as human blood).  No large trials had previously evaluated which fluid resulted in the best outcomes for patients.  Among almost 16,000 patients in 5 intensive care units, the SMART trial found that using balanced crystalloids instead of saline decreased the risk of death, dialysis, or lasting kidney problems.  These findings suggest that most hospitalized patients without a specific reason for receiving saline should be treated with balanced crystalloids when an IV fluid is needed.

Background: Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes.

Methods: In a pragmatic, cluster-randomized, multiple-crossover trial conducted in five intensive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event within 30 days – a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) – all censored at hospital discharge or 30 days, whichever occurred first.

Results: Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P=0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P=0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P=0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P=0.60).

Conclusions: Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779 .).

Manuscript Title: “Balanced Crystalloids versus Saline in Critically Ill Adults.”

Journal: New England Journal of Medicine

PMID: 29485925

Patients in the emergency department are frequently given fluids through an IV as a treatment for a wide variety of injuries and medical complications. Historically, the most common fluid given to patients had been saline.  Saline contains a higher concentration of chloride than that of human blood, which could have negative effects on patients’ kidneys and blood vessels. Another type of fluid, called “balanced crystalloids”, has a chloride concentration more similar to that of human blood.  Whether using balanced crystalloids would result in better outcomes than using saline had been unknown.  Among approximately 13,000 patients receiving fluid in an emergency department prior to admission to the hospital, the  SALT-ED trial found using balanced crystalloids rather than saline did not increase the number of days alive outside the hospital but did decrease patients chances of dying, receiving dialysis, or having lasting kidney problems.  These findings suggest that balanced crystalloids should be used rather than saline for most patients receiving IV fluid in an emergency department.

Background: Comparative clinical effects of balanced crystalloids and saline are uncertain, particularly in noncritically ill patients cared for outside an intensive care unit (ICU).

Methods: We conducted a single-center, pragmatic, multiple-crossover trial comparing balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) with saline among adults who were treated with intravenous crystalloids in the emergency department and were subsequently hospitalized outside an ICU. The type of crystalloid that was administered in the emergency department was assigned to each patient on the basis of calendar month, with the entire emergency department crossing over between balanced crystalloids and saline monthly during the 16-month trial. The primary outcome was hospital-free days (days alive after discharge before day 28). Secondary outcomes included major adverse kidney events within 30 days – a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) – all censored at hospital discharge or 30 days, whichever occurred first.

Results: A total of 13,347 patients were enrolled, with a median crystalloid volume administered in the emergency department of 1079 ml and 88.3% of the patients exclusively receiving the assigned crystalloid. The number of hospital-free days did not differ between the balanced-crystalloids and saline groups (median, 25 days in each group; adjusted odds ratio with balanced crystalloids, 0.98; 95% confidence interval [CI], 0.92 to 1.04; P=0.41). Balanced crystalloids resulted in a lower incidence of major adverse kidney events within 30 days than saline (4.7% vs. 5.6%; adjusted odds ratio, 0.82; 95% CI, 0.70 to 0.95; P=0.01).

Conclusions: Among noncritically ill adults treated with intravenous fluids in the emergency department, there was no difference in hospital-free days between treatment with balanced crystalloids and treatment with saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SALT-ED ClinicalTrials.gov number, NCT02614040 .).

Conflict of interest statement

Dr. Self reports receiving advisory board fees from Venaxis, Cempra Pharmaceuticals, Ferring Pharmaceuticals, and Biotest, consulting fees from Abbott Point of Care, and travel support from Gilead Sciences; and Dr. Rice, receiving consulting fees from Cumberland Pharmaceuticals and Avisa Pharma. No other potential conflict of interest relevant to this article was reported.

Manuscript Title: “Balanced Crystalloids versus Saline in Noncritically Ill Adults.”

Journal: New England Journal of Medicine

PMID: 29485926

For patients being placed on a breathing machine, a breathing tube must be placed in the mouth.  During placement of a breathing tube, low oxygen levels and low blood pressure may occur.  Whether using a checklist prior to placing a breathing tube helps prevent these complications is unknown.  Among 262 patients being placed on a breathing machine at 5 intensive care units across the United States, the CHECK-Up Trial compared use of a checklist to none with regard to the occurrence of low oxygen levels and low blood pressure.  Use of a checklist did not prevent low oxygen levels or low blood pressure.  These findings suggest that using a checklist prior to placing a breathing tube may not be helpful for doctors experienced at placing a breathing tube who work in an intensive care unit.

Background: Hypoxemia and hypotension are common complications during endotracheal intubation of critically ill adults. Verbal performance of a written, preintubation checklist may prevent these complications. We compared a written, verbally performed, preintubation checklist with usual care regarding lowest arterial oxygen saturation or lowest systolic BP experienced by critically ill adults undergoing endotracheal intubation.

Methods: A multicenter trial in which 262 adults undergoing endotracheal intubation were randomized to a written, verbally performed, preintubation checklist (checklist) or no preintubation checklist (usual care). The coprimary outcomes were lowest arterial oxygen saturation and lowest systolic BP between the time of procedural medication administration and 2 min after endotracheal intubation.

Results: The median lowest arterial oxygen saturation was 92% (interquartile range [IQR], 79-98) in the checklist group vs 93% (IQR, 84-100) with usual care (P = .34). The median lowest systolic BP was 112 mm Hg (IQR, 94-133) in the checklist group vs 108 mm Hg (IQR, 90-132) in the usual care group (P = .61). There was no difference between the checklist and usual care in procedure duration (120 vs 118 s; P = .49), number of laryngoscopy attempts (one vs one attempt; P = .42), or severe life-threatening procedural complications (40.8% vs 32.6%; P = .20).

Conclusions: The verbal performance of a written, preprocedure checklist does not increase the lowest arterial oxygen saturation or lowest systolic BP during endotracheal intubation of critically ill adults compared with usual care.

Trial registry: ClinicalTrials.gov; No.: NCT02497729; URL: www.clinicaltrials.gov.

Keywords: adult; airway management; checklist; critical care; endotracheal; intubation; ventilation.

Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Manuscript Title: “A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults.”

Journal: Chest

PMID: 28917549

Patients in the intensive care unit frequently receive IV fluid.  Two basic types of IV fluid exist: saline (which contains more chloride than human blood) and balanced crystalloids (which contains about the same amount of chloride as human blood).  No large trials had previously evaluated which fluid resulted in the best outcomes for patients.  In preparation for a large trial examining this question, the SALT pilot trial aimed to determine whether software tools in the hospital’s electronic health record would produce balanced study groups and divide study participants to either receive balanced crystalloids or saline in a separate and equal way. Results of the study showed that this approach can produce well-balanced study groups and separate the receipt of saline or balanced crystalloids in an effective way.  These findings suggest that electronic health records may be used to efficiently conduct trials comparing treatments commonly used in clinical care.

Rationale: Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown.

Objectives: To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids.

Methods: This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction.

Measurements and main results: Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P < 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98).

Conclusions: An electronic health record-embedded, cluster-randomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt. Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).

Trial registration: ClinicalTrials.gov NCT02345486.

Keywords: acute kidney injury; critical illness; crystalloid; intravenous fluid; saline.

Manuscript Title: “Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.”

Journal: American Journal of Respiratory and Critical Care Medicine

PMID: 27749094

To support seriously ill patients with a breathing machine, doctors must place a breathing tube.  One-in-five times doctors cannot place the breathing tube on the first try.  When the breathing tube cannot be placed on the first try, the risks to the patient for low oxygen levels or blood pressure are higher.  Two types of tools exist for helping see a patients’ vocal cords to place a breathing tube: a device with a camera on it (video laryngoscope) and a device without a camera on it (direct laryngoscope).  Whether placing a breathing tube on the first try is easier with a video laryngoscope or a direct laryngoscope is unknown.  Among 150 patients receiving a breathing tube in one intensive care unit, the FELLOW trial found that, while a video laryngoscope made it easier to see the vocal cords, using a video laryngoscope did not make it easier to place a breathing tube on the first try compared with using a direct laryngoscope.  These findings suggest the need for large, multicenter trials examining whether use of a video laryngoscope can make it easier to place a breathing tube on the first try.

Objective: To evaluate the effect of video laryngoscopy on the rate of endotracheal intubation on first laryngoscopy attempt among critically ill adults.

Design: A randomized, parallel-group, pragmatic trial of video compared with direct laryngoscopy for 150 adults undergoing endotracheal intubation by Pulmonary and Critical Care Medicine fellows.

Setting: Medical ICU in a tertiary, academic medical center.

Patients: Critically ill patients 18 years old or older.

Interventions: Patients were randomized 1:1 to video or direct laryngoscopy for the first attempt at endotracheal intubation.

Measurements and main results: Patients assigned to video (n = 74) and direct (n = 76) laryngoscopy were similar at baseline. Despite better glottic visualization with video laryngoscopy, there was no difference in the primary outcome of intubation on the first laryngoscopy attempt (video 68.9% vs direct 65.8%; p = 0.68) in unadjusted analyses or after adjustment for the operator’s previous experience with the assigned device (odds ratio for video laryngoscopy on intubation on first attempt 2.02; 95% CI, 0.82-5.02, p = 0.12). Secondary outcomes of time to intubation, lowest arterial oxygen saturation, complications, and in-hospital mortality were not different between video and direct laryngoscopy.

Conclusions: In critically ill adults undergoing endotracheal intubation, video laryngoscopy improves glottic visualization but does not appear to increase procedural success or decrease complications.

Manuscript Title: “Randomized Trial of Video Laryngoscopy for Endotracheal Intubation of Critically Ill Adults.”

Journal: Critical Care Medicine

PMID: 27355526

Low oxygen levels is the most common complication that arises when a critically ill patient is being placed on a breathing machine. Whether providing oxygen with a small tube below the nose (“nasal cannula”) during the placement of a breathing tube prevents low oxygen levels had been unknown.  Among 150 patients receiving a breathing tube in one intensive care unit, the FELLOW Trial found that giving oxygen through a nasal cannula during the placement of a breathing tube did not prevent low oxygen levels.  These findings suggest that doctors should focus on other treatments that may prevent low oxygen levels during placement of a breathing tube.

Rationale: Hypoxemia is common during endotracheal intubation of critically ill patients and may predispose to cardiac arrest and death. Administration of supplemental oxygen during laryngoscopy (apneic oxygenation) may prevent hypoxemia.

Objectives: To determine if apneic oxygenation increases the lowest arterial oxygen saturation experienced by patients undergoing endotracheal intubation in the intensive care unit.

Methods: This was a randomized, open-label, pragmatic trial in which 150 adults undergoing endotracheal intubation in a medical intensive care unit were randomized to receive 15 L/min of 100% oxygen via high-flow nasal cannula during laryngoscopy (apneic oxygenation) or no supplemental oxygen during laryngoscopy (usual care). The primary outcome was lowest arterial oxygen saturation between induction and 2 minutes after completion of endotracheal intubation.

Measurements and main results: Median lowest arterial oxygen saturation was 92% with apneic oxygenation versus 90% with usual care (95% confidence interval for the difference, -1.6 to 7.4%; P = 0.16). There was no difference between apneic oxygenation and usual care in incidence of oxygen saturation less than 90% (44.7 vs. 47.2%; P = 0.87), oxygen saturation less than 80% (15.8 vs. 25.0%; P = 0.22), or decrease in oxygen saturation greater than 3% (53.9 vs. 55.6%; P = 0.87). Duration of mechanical ventilation, intensive care unit length of stay, and in-hospital mortality were similar between study groups.

Conclusions: Apneic oxygenation does not seem to increase lowest arterial oxygen saturation during endotracheal intubation of critically ill patients compared with usual care. These findings do not support routine use of apneic oxygenation during endotracheal intubation of critically ill adults. Clinical trial registered with www.clinicaltrials.gov (NCT 02051816).

Manuscript Title: “Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill.”

Journal: American Journal of Respiratory and Critical Care Medicine

PMID: 27355526

When a patient requiring a breathing machine is ready to be disconnected from that machine, providing additional oxygen support using a mask over the patient’s mouth (called “non-invasive ventilation”) or a large tube under their nose (called “high flow nasal cannula”) had been reported to decrease the likelihood of the patient needing to be put back on the breathing machine. The PROPER Trial assessed over 750 intensive care unit patients to determine whether additional oxygen support with non-invasive ventilation or high flow nasal cannula reduced the need to go back on a breathing machine within 96 hours after initially being taken off. The results showed that receiving the additional support did not prevent the need to go back on a breathing machine. These findings suggest doctors can provide support with the devices for some patients who they think will benefit, but do not need to provide support with these devices for every patient.

Rationale: Respiratory support (noninvasive ventilation or high-flow nasal cannula) applied at the time of extubation has been reported to reduce reintubation rates, but concerns regarding effectiveness have limited uptake into practice.

Objectives: To determine if providing postextubation respiratory support to all patients undergoing extubation in a medical ICU would decrease the incidence of reintubation.

Methods: We conducted a pragmatic, two-armed, cluster-crossover trial of adults undergoing extubation from invasive mechanical ventilation between October 1, 2017, and March 31, 2019, in the medical ICU of an academic medical center. Patients were assigned to either protocolized postextubation respiratory support (a respiratory therapist-driven protocol in which patients with suspected hypercapnia received noninvasive ventilation and patients without suspected hypercapnia received high-flow nasal cannula) or usual care (postextubation management at the discretion of treating clinicians). The primary outcome was reintubation within 96 hours of extubation.

Measurements and Main Results: A total of 751 patients were enrolled. Of the 359 patients assigned to protocolized support, 331 (92.2%) received postextubation respiratory support compared with 66 of 392 patients (16.8%) assigned to usual care, a difference driven by differential use of high-flow nasal cannula (74.7% vs. 2.8%). A total of 57 patients (15.9%) in the protocolized support group experienced reintubation compared with 52 patients (13.3%) in the usual care group (odds ratio, 1.23; 95% confidence interval, 0.82 to 1.84; P = 0.32).

Conclusions: Among a broad population of critically ill adults undergoing extubation from invasive mechanical ventilation at an academic medical center, protocolized postextubation respiratory support, primarily characterized by an increase in the use of high-flow nasal cannula, did not prevent reintubation compared with usual care.Clinical trial registered with www.clinicaltrials.gov (NCT0328831).

Trial registration: ClinicalTrials.gov NCT03288311.

Keywords: invasive mechanical ventilation; noninvasive respiratory support; reintubation.

Manuscript Title: “Protocolized Postextubation Respiratory Support to Prevent Reintubation: A Randomized Clinical Trial.”

Journal: American Journal of Respiratory and Critical Care Medicine

PMID: 33794131

Vanderbilt University Medical Center.

MS, Statistics and Biological Engineering, University of Georgia

Primary collaboration: Vanderbilt Institute for Clinical and Translational Research (VICTR).

Research interests include: clinical prediction models, pragmatic clinical trials, statistical computing, mixed-effects models, time-to-event analysis

Vanderbilt University Medical Center

Christopher Lindsell is a collaborative biostatistician who is a leader in the application of rigorous of biostatistical methods in the acute care environment, and to the intersection between emergency care and public health. He has led data coordinating centers for numerous multi-center clinical trials, including FDA-regulated trials, and for epidemiological studies. He holds patents on risk stratification in septic shock, and he has contributed significantly to a number of NIH-funded networks, including the CTSA. His current focus is on learning health systems, leveraging clinical processes and data systems to enhance learning from pragmatic trials and observational studies, and for designing and implementing dissemination and implementation research.

Wake Forest School of Medicine

Vanderbilt University Medical Center

Dr. Self is a physician-scientist focusing on improving the treatment of patients with infectious diseases and critical illness in the emergency department. His research involves disease entities such as pneumonia, sepsis, influenza, and soft tissue infections. He leads emergency department-based clinical trials, epidemiologic studies, and patient safety initiatives.

Vanderbilt University Medical Center

Vanderbilt University Medical Center

David R Janz, MD, MSc
Louisiana State University School of Medicine 
Director of Medical Critical Care Services at University Medical Center. I earned my medical degree at the LSU School of Medicine New Orleans followed by completion of an Internal Medicine residency, Pulmonary/Critical Care fellowship and Masters of Science in Clinical Investigation at Vanderbilt University, Nashville, TN. I am board certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine.

University of Alabama at Birmingham Medical Center
Dr. Russell received his initial medical training (MD) at the University of Texas Medical Branch with his internal medicine internship and residency completed at Vanderbilt University. Dr. Russell began a clinical and research fellowship in pulmonary and critical care medicine at UAB in 2014. Following his fellowship, he joined the UAB faculty in July 2017. His research and clinical interests relate to the role of neutrophils and extracellular vesicles in pulmonary diseases characterized by neutrophilic inflammation and parenchymal damage such as COPD and ARDS, as well as pragmatic clinical trials on the management of critically ill patients. Dr. Russell has published and presented work on endotracheal intubation, management of respiratory failure, pragmatic clinical trials in the MICU, neutrophils in COPD, matrikines in COPD, exhaled breath biomarkers in ARDS and extracellular vesicles in neutrophilic inflammation. His ongoing work explores the role of neutrophil-derived exosomes in matrix destruction and lung disease.

University of Alabama at Birmingham Medical Center
Dr. Sheetal Gandotra is a pulmonary physician who began her work at UAB in 2018. She received her medical degree from Saba University School of Medicine.

Brian E Driver, MD
Hennepin County Medical Center, Minneapolis, MN 

Dr. Driver is board certified in both Emergency Medicine and Internal Medicine. He has expertise in caring for all acute illness and injuries, with particular interests in emergency airway management and metabolic disorders.

Matthew E Prekker, MD MPH
Hennepin County Medical Center, Minneapolis, MN 

Through specialization in both Emergency Medicine and Pulmonary & Critical Care Medicine, Dr. Prekker provides acute care for patients in the Emergency Department and Medical ICU as well as maintaining a practice as a pulmonary consultant and clinic physician. He has special expertise in resuscitation from critical illness, including airway management, mechanical ventilation, and extracorporeal membrane oxygenation.

Stacy Trent, MD
Emergency Physician, Denver Health Medical Center, Denver, USA

Stacy A. Trent, MD, MPH is an emergency physician and Associate Director of Research in the Department of Emergency Medicine at Denver Health Medical Center.  Dr. Trent’s is a federally-funded researcher whose work focuses on examining and mitigating variation in evidence-based care for airway management, sepsis, and acute coronary syndrome.  Dr. Trent is a member of the executive committee for the Pragmatic Critical Care Research Group, is member of the NHLBI PETAL network serving as a site investigator for the CLOVERS study and is also a member of the NIH SIREN network. 

Twitter:  @drstrent

Director of the Coordinating Center: Jonathan D. Casey, MD, MSc – Vanderbilt University Medical Center

Jonathan D. Casey MD, MSc is an Assistant Professor of Medicine in the Division of Allergy, Pulmonary, and Critical Care Medicine at Vanderbilt University and a critical care physician in the Medical Intensive Care Unit at Vanderbilt University. Dr. Casey’s work focuses on embedding pragmatic comparative effectiveness trials of standard-of-care interventions into routine care in the emergency department and intensive care unit.  His work aims to answer long-standing questions in airway management, post-extubation respiratory support, extracorporeal membrane oxygenation, and COVID-19.  These efforts have resulted in multiple practice-changing trials published in the New England Journal of Medicine, the Journal of the American Medical Association, and the American Journal of Respiratory and Critical Care Medicine.  Dr. Casey serves as Chair of the Coordinating Center for the Pragmatic Critical Care Research Group and as a member of the NHLBI-funded PETAL Network and the CDC-funded IVY network.

Twitter:  @JonathanCaseyMD

Chair of the Steering Committee: Matthew W. Semler, MD, MSc – Vanderbilt University Medical Center

Matthew W. Semler MD, MSc is an Assistant Professor of Medicine and Biomedical Informatics in the Division of Allergy, Pulmonary, and Critical Care Medicine at Vanderbilt University. Dr. Semler is a critical care physician and Associate Director of the Medical Intensive Care Unit at Vanderbilt University. Dr. Semler’s federally-funded research identifies non-patient-centered variation in current clinical practice, embeds pragmatic randomized trials into clinical care to understand which treatments produce the best outcomes for which patients, and implements the results into practice. Randomized trials he has helped lead, including six published in the New England Journal of Medicine or JAMA, have challenged longstanding dogma around common practices in fluid management, airway management, and respiratory support. Dr. Semler serves as Chair of the Steering Committee for the Pragmatic Critical Care Research Group, co-director of the Inpatient Division of the Learning Healthcare System at Vanderbilt University, and a member of the protocol committee for trials within the NHLBI PETAL Network.

Journal: Journal of Neurotrauma
PMID: 35443809

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 35549663

For patients on a breathing machine, doctors may secure the breathing tube in place using either adhesive tape or an endotracheal tube fastener.  The ETTS Trial compared the securement technique of adhesive tape versus an endotracheal tube fastener for patients in the medical intensive care unit expected to require a breathing machine for more than 24 hours. Safety and efficacy of the two techniques were compared by evaluating the presence of lip ulcers, the tube becoming dislodged from the patient, ventilator-associated pneumonia, or facial skin tears. Results of the study showed that the use of the endotracheal tube fastener reduced the rate of lip ulcers, tube dislodgement, and skin tears compared to the use of adhesive tape. The findings suggest that using an endotracheal tube fastener will reduce the rate of these events, may improve patient safety, and may decrease the cost of care.

Background: The optimal securement method of endotracheal tubes is unknown but should prevent dislodgement while minimizing complications. The use of an endotracheal tube fastener might reduce complications among critically ill adults undergoing endotracheal intubation.

Methods: In this pragmatic, single-center, randomized trial, critically ill adults admitted to the medical intensive care unit (MICU) and expected to require invasive mechanical ventilation for greater than 24 h were randomized to adhesive tape or endotracheal tube fastener at the time of intubation. The primary endpoint was a composite of any of the following: presence of lip ulcer, endotracheal tube dislodgement (defined as moving at least 2 cm), ventilator-associated pneumonia, or facial skin tears anytime between randomization and the earlier of death or 48 h after extubation. Secondary endpoints included duration of mechanical ventilation and ICU and in-hospital mortality.

Results: Of 500 patients randomized over a 12-month period, 162 had a duration of mechanical ventilation less than 24 h and 40 had missing outcome data, leaving 153 evaluable patients randomized to tube fastener and 145 evaluable patients randomized to adhesive tape. Baseline characteristics were similar between the groups. The primary endpoint occurred 13 times in 12 (7.8%) patients in the tube fastener group and 30 times in 25 (17.2%) patients in the adhesive tape group (p = 0.014) for an overall incidence of 22.0 versus 52.6 per 1000 ventilator days, respectively (p = 0.020). Lip ulcers occurred in 4 (2.6%) versus 11 (7.3%) patients, or an incidence rate of 6.5 versus 19.5 per 1000 patient ventilator days (p = 0.053) in the fastener and tape groups, respectively. The endotracheal tube was dislodged 7 times in 6 (3.9%) patients in the tube fastener group and 16 times in 15 (10.3%) patients in the tape group (p = 0.03), reflecting incidences of 11.9 and 28.1 per 1000 ventilator days, respectively. Facial skin tears were similar between the groups. Mechanical ventilation duration and ICU and hospital mortality did not differ.

Conclusion: The use of the endotracheal tube fastener to secure the endotracheal tubes reduces the rate of a composite outcome that included lip ulcers, facial skin tears, or endotracheal tube dislodgement compared to adhesive tape.

Trial registration: ClinicalTrials.gov NCT03760510. Retrospectively registered on November 30, 2018.

Keywords: Critical care; Endotracheal tube; Endotracheal tube dislodgement; Facial skin tear; Intensive care units; Lip ulcer; Mechanical ventilation; Tube fastener.

Manuscript Title: “The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial.”

Journal: Critical Care

PMID: 31064406