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