Dataset Information

DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation.

ABSTRACT:

Introduction

Among critically ill patients undergoing orotracheal intubation in the emergency department (ED) or intensive care unit (ICU), failure to visualise the vocal cords and intubate the trachea on the first attempt is associated with an increased risk of complications. Two types of laryngoscopes are commonly available: direct laryngoscopes and video laryngoscopes. For critically ill adults undergoing emergency tracheal intubation, it remains uncertain whether the use of a video laryngoscope increases the incidence of successful intubation on the first attempt compared with the use of a direct laryngoscope.

Methods and analysis

The DirEct versus VIdeo LaryngosCopE (DEVICE) trial is a prospective, multicentre, non-blinded, randomised trial being conducted in 7 EDs and 10 ICUs in the USA. The trial plans to enrol up to 2000 critically ill adults undergoing orotracheal intubation with a laryngoscope. Eligible patients are randomised 1:1 to the use of a video laryngoscope or a direct laryngoscope for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is the incidence of severe complications between induction and 2 min after intubation, defined as the occurrence of one or more of the following: severe hypoxaemia (lowest oxygen saturation <80%); severe hypotension (systolic blood pressure <65 mm Hg or new or increased vasopressor administration); cardiac arrest or death. Enrolment began on 19 March 2022 and is expected to be completed in 2023.

Ethics and dissemination

The trial protocol was approved with waiver of informed consent by the single institutional review board at Vanderbilt University Medical Center and the Human Research Protection Office of the Department of Defense. The results will be presented at scientific conferences and submitted for publication in a peer-reviewed journal.

Trial registration number

ClinicalTrials.gov Registry (NCT05239195).

SUBMITTER: Prekker ME

PROVIDER: S-EPMC9843219 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation.

Prekker Matthew E ME Driver Brian E BE Trent Stacy A SA Resnick-Ault Daniel D Seitz Kevin K Russell Derek W DW Gandotra Sheetal S Gaillard John P JP Gibbs Kevin W KW Latimer Andrew A Whitson Micah R MR Ghamande Shekhar S Vonderhaar Derek J DJ Walco Jeremy P JP Hansen Sydney J SJ Douglas Ivor S IS Barnes Christopher R CR Krishnamoorthy Vijay V Bastman Jill J JJ Lloyd Bradley Daniel BD Robison Sarah W SW Palakshappa Jessica A JA Mitchell Steven S Page David B DB White Heath D HD Espinera Alyssa A Hughes Christopher C Joffe Aaron M AM Herbert J Taylor JT Schauer Steven G SG Long Brit J BJ Imhoff Brant B Wang Li L Rhoads Jillian P JP Womack Kelsey N KN Janz David D Self Wesley H WH Rice Todd W TW Ginde Adit A AA Casey Jonathan D JD Semler Matthew W MW

BMJ open 20230113 1

<h4>Introduction</h4>Among critically ill patients undergoing orotracheal intubation in the emergency department (ED) or intensive care unit (ICU), failure to visualise the vocal cords and intubate the trachea on the first attempt is associated with an increased risk of complications. Two types of laryngoscopes are commonly available: direct laryngoscopes and video laryngoscopes. For critically ill adults undergoing emergency tracheal intubation, it remains uncertain whether the use of a video l ...[more]

PMID: 36639210

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Project description:BackgroundHypoxemia 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.MethodsIn 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%.ResultsAmong 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).ConclusionsAmong 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.).

Project description:UnlabelledThe aim of the present study was to evaluate whether the TruView video laryngoscope (TruView) facilitates pediatric endotracheal intubation (ETI) more quickly and safely than conventional Macintosh laryngoscope (MAC) in three manikin-based airway scenarios. This was a randomized crossover manikin study including 120 novice paramedics. The participants performed tracheal intubations using both TruView and MAC on a pediatric manikin in a control scenario (A), chest compression scenario (B), and chest compression cervical stabilization scenario (C). The sequence of scenarios was randomized. The primary outcome was time to intubation. Secondary outcomes were overall success rates, incidence of dental trauma, and ease of intubation. All intubation attempts were assessed by a trained assistant. The overall success rate was significantly higher with the TruView compared than the MAC in scenario B (100 vs. 81.7 %; p = 0.011) and scenario C (100 vs. 68.3 %; p < 0.001). The intubation time was significantly lower with the TruView than the MAC (18.5 vs. 24.3 s, p = 0.017, for scenario A; 21.6 vs. 25.7 s, p = 0.023, for scenario B; and 28.9 vs. 45.4 s, p < 0.001, for scenario C). Glottic view quality was better with TruView than the MAC in all scenarios, p < 0.001.ConclusionsThe TruView offers better intubation conditions than the MAC on a pediatric manikin in the control scenario, chest compression scenario, and chest compression scenario with cervical stabilization scenario. The TruView may be used to elevate the epiglottis for orotracheal intubation. Further clinical studies are necessary to confirm these initial positive findings.Trial registrationclinicaltrials.gov Identifier: NCT02289872.What is known•Prehospital pediatric intubation using a standard laryngoscope is varied and ranges from 63.4 to 82 %. What is New: •This is the first study showing efficiency of pediatric endotracheal intubation using the TruView PCD by paramedics in tree simulation scenarios. •TruView PCD offers better pediatric intubation conditions than the Macintosh laryngoscope.

Project description:ImportanceHypotension is common during tracheal intubation of critically ill adults and increases the risk of cardiac arrest and death. Whether administering an intravenous fluid bolus to critically ill adults undergoing tracheal intubation prevents severe hypotension, cardiac arrest, or death remains uncertain.ObjectiveTo determine the effect of fluid bolus administration on the incidence of severe hypotension, cardiac arrest, and death.Design, setting, and participantsThis randomized clinical trial enrolled 1067 critically ill adults undergoing tracheal intubation with sedation and positive pressure ventilation at 11 intensive care units in the US between February 1, 2019, and May 24, 2021. The date of final follow-up was June 21, 2021.InterventionsPatients were randomly assigned to receive either a 500-mL intravenous fluid bolus (n = 538) or no fluid bolus (n = 527).Main outcomes and measuresThe primary outcome was cardiovascular collapse (defined as new or increased receipt of vasopressors or a systolic blood pressure <65 mm Hg between induction of anesthesia and 2 minutes after tracheal intubation, or cardiac arrest or death between induction of anesthesia and 1 hour after tracheal intubation). The secondary outcome was the incidence of death prior to day 28, which was censored at hospital discharge.ResultsAmong 1067 patients randomized, 1065 (99.8%) completed the trial and were included in the primary analysis (median age, 62 years [IQR, 51-70 years]; 42.1% were women). Cardiovascular collapse occurred in 113 patients (21.0%) in the fluid bolus group and in 96 patients (18.2%) in the no fluid bolus group (absolute difference, 2.8% [95% CI, -2.2% to 7.7%]; P = .25). New or increased receipt of vasopressors occurred in 20.6% of patients in the fluid bolus group compared with 17.6% of patients in the no fluid bolus group, a systolic blood pressure of less than 65 mm Hg occurred in 3.9% vs 4.2%, respectively, cardiac arrest occurred in 1.7% vs 1.5%, and death occurred in 0.7% vs 0.6%. Death prior to day 28 (censored at hospital discharge) occurred in 218 patients (40.5%) in the fluid bolus group compared with 223 patients (42.3%) in the no fluid bolus group (absolute difference, -1.8% [95% CI, -7.9% to 4.3%]; P = .55).Conclusions and relevanceAmong critically ill adults undergoing tracheal intubation, administration of an intravenous fluid bolus compared with no fluid bolus did not significantly decrease the incidence of cardiovascular collapse.Trial registrationClinicalTrials.gov Identifier: NCT03787732.

Project description:BackgroundTracheal 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.MethodsWe 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.FindingsPatients 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%]).InterpretationAdministration 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.FundingUS National Institutes of Health.

Project description:BACKGROUND:We performed a systematic review of randomized controlled studies evaluating any drug, technique or device aimed at improving the success rate or safety of tracheal intubation in the critically ill. METHODS:We searched PubMed, BioMed Central, Embase and the Cochrane Central Register of Clinical Trials and references of retrieved articles. Finally, pertinent reviews were also scanned to detect further studies until May 2017. The following inclusion criteria were considered: tracheal intubation in adult critically ill patients; randomized controlled trial; study performed in Intensive Care Unit, Emergency Department or ordinary ward; and work published in the last 20 years. Exclusion criteria were pre-hospital or operating theatre settings and simulation-based studies. Two investigators selected studies for the final analysis. Extracted data included first author, publication year, characteristics of patients and clinical settings, intervention details, comparators and relevant outcomes. The risk of bias was assessed with the Cochrane Collaboration's Risk of Bias tool. RESULTS:We identified 22 trials on use of a pre-procedure check-list (1 study), pre-oxygenation or apneic oxygenation (6 studies), sedatives (3 studies), neuromuscular blocking agents (1 study), patient positioning (1 study), video laryngoscopy (9 studies), and post-intubation lung recruitment (1 study). Pre-oxygenation with non-invasive ventilation (NIV) and/or high-flow nasal cannula (HFNC) showed a possible beneficial role. Post-intubation recruitment improved oxygenation, while ramped position increased the number of intubation attempts and thiopental had negative hemodynamic effects. No effect was found for use of a checklist, apneic oxygenation (on oxygenation and hemodynamics), videolaryngoscopy (on number and length of intubation attempts), sedatives and neuromuscular blockers (on hemodynamics). Finally, videolaryngoscopy was associated with severe adverse effects in multiple trials. CONCLUSIONS:The limited available evidence supports a beneficial role of pre-oxygenation with NIV and HFNC before intubation of critically ill patients. Recruitment maneuvers may increase post-intubation oxygenation. Ramped position increased the number of intubation attempts; thiopental had negative hemodynamic effects and videolaryngoscopy might favor adverse events.

Project description:RationaleHypoxemia is a common complication during tracheal intubation of critically ill adults and is a frequently used endpoint in airway management research. Identifying patients likely to experience low oxygen saturations during tracheal intubation may be useful for clinical practice and clinical trials.ObjectivesTo identify risk factors for lower oxygen saturations and severe hypoxemia during tracheal intubation of critically ill adults and develop prediction models for lowest oxygen saturation and hypoxemia.MethodsUsing data on 433 intubations from two randomized trials, we developed linear and logistic regression models to identify preprocedural risk factors for lower arterial oxygen saturations and severe hypoxemia between induction and 2 minutes after intubation. Penalized regression was used to develop prediction models for lowest oxygen saturation after induction and severe hypoxemia. A simplified six-point score was derived to predict severe hypoxemia.ResultsAmong the 433 intubations, 426 had complete data and were included in the model. The mean (standard deviation) lowest oxygen saturation was 88% (14%); median (interquartile range) was 93% (83-98%). Independent predictors of severe hypoxemia included hypoxemic respiratory failure as the indication for intubation (odds ratio [OR], 2.70; 95% confidence interval [CI], 1.58-4.60), lower oxygen saturation at induction (OR, 0.92 per 1% increase; 95% CI, 0.89-0.96 per 1% increase), younger age (OR, 0.97 per 1-year increase; 95% CI, 0.95-0.99 per 1-year increase), higher body mass index (OR, 1.03 per 1 kg/m2; 95% CI, 1.00-1.06 per 1 kg/m2), race (OR, 4.58 for white vs. black; 95% CI, 1.97-10.67; OR, 4.47 for other vs. black; 95% CI, 1.19-16.84), and operator with fewer than 100 prior intubations (OR, 2.83; 95% CI, 1.37-5.85). A six-point score using the identified risk factors predicted severe hypoxemia with an area under the receiver operating curve of 0.714 (95% CI, 0.653 to 0.778).ConclusionsLowest oxygen saturation and severe hypoxemia during tracheal intubation in the intensive care unit can be accurately predicted using routinely available preprocedure clinical data, with saturation at induction and hypoxemic respiratory failure being the strongest predictors. A simple bedside score may identify patients at risk for hypoxemia during intubation to help target preventative interventions and facilitate enrichment in clinical trials.

Dataset Information

DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation.

Similar Datasets

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