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

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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Results of Randomized Trials

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

May 2019
Posted on by briserv

Journal: Critical Care
PMID: 31064406

Link to PubMed

Past Trials

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PreVent Trial

Feb 2019
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Low oxygen level is the most common complication that arises when a critically ill patient is being placed on a breathing machine. Whether providing oxygen and ventilation with a bag-mask device prior to placement of a breathing tube prevents low oxygen levels had been unknown.  Among 401 patients in 7 intensive care units, the PreVent trial found that providing oxygen and ventilation with a bag-mask device was safe, maintained higher oxygen level and prevented dangerously low oxygen levels.  These findings may improve the safety of breathing tube placement for many seriously ill adults.

Background: Hypoxemia is the most common complication during tracheal intubation of critically ill adults and may increase the risk of cardiac arrest and death. Whether positive-pressure ventilation with a bag-mask device (bag-mask ventilation) during tracheal intubation of critically ill adults prevents hypoxemia without increasing the risk of aspiration remains controversial.

Methods: In a multicenter, randomized trial conducted in seven intensive care units in the United States, we randomly assigned adults undergoing tracheal intubation to receive either ventilation with a bag-mask device or no ventilation between induction and laryngoscopy. The primary outcome was the lowest oxygen saturation observed during the interval between induction and 2 minutes after tracheal intubation. The secondary outcome was the incidence of severe hypoxemia, defined as an oxygen saturation of less than 80%.

Results: Among the 401 patients enrolled, the median lowest oxygen saturation was 96% (interquartile range, 87 to 99) in the bag-mask ventilation group and 93% (interquartile range, 81 to 99) in the no-ventilation group (P = 0.01). A total of 21 patients (10.9%) in the bag-mask ventilation group had severe hypoxemia, as compared with 45 patients (22.8%) in the no-ventilation group (relative risk, 0.48; 95% confidence interval [CI], 0.30 to 0.77). Operator-reported aspiration occurred during 2.5% of intubations in the bag-mask ventilation group and during 4.0% in the no-ventilation group (P = 0.41). The incidence of new opacity on chest radiography in the 48 hours after tracheal intubation was 16.4% and 14.8%, respectively (P = 0.73).

Conclusions: Among critically ill adults undergoing tracheal intubation, patients receiving bag-mask ventilation had higher oxygen saturations and a lower incidence of severe hypoxemia than those receiving no ventilation. (Funded by Vanderbilt Institute for Clinical and Translational Research and others; PreVent ClinicalTrials.gov number, NCT03026322.).

Manuscript Title: “Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults.”

Journal: New England Journal of Medicine

PMID: 30779528

Secondary Analyses of Clinical Trial Results

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Risk Factors for and Prediction of Hypoxemia during Tracheal Intubation of Critically Ill Adults.

Oct 2018
Posted on by briserv

Journal: Annals of the American Thoracic Society
PMID: 30109943

Link to PubMed

Secondary Analyses of Clinical Trial Results

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Heterogeneity of Treatment Effect by Baseline Risk in a Trial of Balanced Crystalloids versus Saline.

Sep 2018
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Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 29897785

Link to PubMed

Trial Statistical Analysis Plans

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Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial.

Aug 2018
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Journal: BMJ Open
PMID: 30099400

Link to PubMed

Results of Randomized Trials

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A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults.

Apr 2018
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Journal: Chest
PMID: 28917549
Category: Clinical Trial Results (CHECK-Up Trial: Checklist)

Link to PubMed
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