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Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial.

ABSTRACT: Importance:The tracheal tube introducer, known as the bougie, is typically used to aid tracheal intubation in poor laryngoscopic views or after intubation attempts fail. The effect of routine bougie use on first-attempt intubation success is unclear. Objective:To compare first attempt intubation success facilitated by the bougie vs the endotracheal tube?+?stylet. Design, Setting, and Patients:The Bougie Use in Emergency Airway Management (BEAM) trial was a randomized clinical trial conducted from September 2016 through August 2017 in the emergency department at Hennepin County Medical Center, an urban, academic department in Minneapolis, Minnesota, where emergency physicians perform all endotracheal intubations. Included patients were 18 years and older who were consecutively admitted to the emergency department and underwent emergency orotracheal intubation with a Macintosh laryngoscope blade for respiratory arrest, difficulty breathing, or airway protection. Interventions:Patients were randomly assigned to undergo the initial intubation attempt facilitated by bougie (n?=?381) or endotracheal tube?+?stylet (n?=?376). Main Outcomes and Measures:The primary outcome was first-attempt intubation success in patients with at least 1 difficult airway characteristic (body fluids obscuring the laryngeal view, airway obstruction or edema, obesity, short neck, small mandible, large tongue, facial trauma, or the need for cervical spine immobilization). Secondary outcomes were first-attempt success in all patients, first-attempt intubation success without hypoxemia, first-attempt duration, esophageal intubation, and hypoxemia. Results:Among 757 patients who were randomized (mean age, 46 years; women, 230 [30%]), 757 patients (100%) completed the trial. Among the 380 patients with at least 1 difficult airway characteristic, first-attempt intubation success was higher in the bougie group (96%) than in the endotracheal tube?+?stylet group (82%) (absolute between-group difference, 14% [95% CI, 8% to 20%]). Among all patients, first-attempt intubation success in the bougie group (98%) was higher than the endotracheal tube?+?stylet group (87%) (absolute difference, 11% [95% CI, 7% to 14%]). The median duration of the first intubation attempt (38 seconds vs 36 seconds) and the incidence of hypoxemia (13% vs 14%) did not differ significantly between the bougie and endotracheal tube?+?stylet groups. Conclusions and Relevance:In this emergency department, use of a bougie compared with an endotracheal tube?+?stylet resulted in significantly higher first-attempt intubation success among patients undergoing emergency endotracheal intubation. However, these findings should be considered provisional until the generalizability is assessed in other institutions and settings. Trial Registration:clinicaltrials.gov Identifier: NCT02902146.

SUBMITTER: Driver BE

PROVIDER: S-EPMC6134434 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial.

Driver Brian E BE Prekker Matthew E ME Klein Lauren R LR Reardon Robert F RF Miner James R JR Fagerstrom Erik T ET Cleghorn Mitchell R MR McGill John W JW Cole Jon B JB

JAMA 20180601 21

<h4>Importance</h4>The tracheal tube introducer, known as the bougie, is typically used to aid tracheal intubation in poor laryngoscopic views or after intubation attempts fail. The effect of routine bougie use on first-attempt intubation success is unclear.<h4>Objective</h4>To compare first attempt intubation success facilitated by the bougie vs the endotracheal tube + stylet.<h4>Design, setting, and patients</h4>The Bougie Use in Emergency Airway Management (BEAM) trial was a randomized clinic ...[more]

PMID: 29800096

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Project description:ImportanceFor 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. Whether using a tracheal tube introducer ("bougie") increases the likelihood of successful intubation compared with using an endotracheal tube with stylet remains uncertain.ObjectiveTo determine the effect of use of a bougie vs an endotracheal tube with stylet on successful intubation on the first attempt.Design, setting, and participantsThe Bougie or Stylet in Patients Undergoing Intubation Emergently (BOUGIE) trial was a multicenter, randomized clinical trial among 1102 critically ill adults undergoing tracheal intubation in 7 emergency departments and 8 intensive care units in the US between April 29, 2019, and February 14, 2021; the date of final follow-up was March 14, 2021.InterventionsPatients were randomly assigned to use of a bougie (n = 556) or use of an endotracheal tube with stylet (n = 546).Main outcomes and measuresThe primary outcome was successful intubation on the first attempt. The secondary outcome was the incidence of severe hypoxemia, defined as a peripheral oxygen saturation less than 80%.ResultsAmong 1106 patients randomized, 1102 (99.6%) completed the trial and were included in the primary analysis (median age, 58 years; 41.0% women). Successful intubation on the first attempt occurred in 447 patients (80.4%) in the bougie group and 453 patients (83.0%) in the stylet group (absolute risk difference, -2.6 percentage points [95% CI, -7.3 to 2.2]; P = .27). A total of 58 patients (11.0%) in the bougie group experienced severe hypoxemia, compared with 46 patients (8.8%) in the stylet group (absolute risk difference, 2.2 percentage points [95% CI, -1.6 to 6.0]). Esophageal intubation occurred in 4 patients (0.7%) in the bougie group and 5 patients (0.9%) in the stylet group, pneumothorax was present after intubation in 14 patients (2.5%) in the bougie group and 15 patients (2.7%) in the stylet group, and injury to oral, glottic, or thoracic structures occurred in 0 patients in the bougie group and 3 patients (0.5%) in the stylet group.Conclusions and relevanceAmong critically ill adults undergoing tracheal intubation, use of a bougie did not significantly increase the incidence of successful intubation on the first attempt compared with use of an endotracheal tube with stylet.Trial registrationClinicalTrials.gov Identifier: NCT03928925

Project description:IntroductionTracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.Methods and analysisThe endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.Ethics and disseminationThe study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.Trial registration detailsClinicalTrials.gov Identifier: NCT04079387; Pre-results.

Project description:BACKGROUND:Incidence of difficult endotracheal intubation ranges between 3 and 10%. Bougies have been recommended as an airway adjunct for difficult intubation, but reported success rates are variable. A new generation flexible tip bougie appears promising but was not investigated so far. We therefore compared the new flexible tip with a standard bougie in simulated normal and difficult airway scenarios, and used by experienced anesthesiologists. METHODS:We conducted a observational, randomized, cross-over simulation study. Following standardized training, experienced anesthesiologists performed endotracheal intubation using a Macintosh blade and one of the bougies in six different airway scenarios in a randomized sequence: normal airway, tongue edema, pharyngeal obstruction, manual cervical inline stabilization, cervical collar stabilization, cervical collar stabilization and pharyngeal obstruction. Overall success rate with a maximum of 3 intubation attempts was the primary endpoint. Secondary endpoints included number of intubation attempts, time to intubation and dental compression. RESULTS:Thirty-two anesthesiologist participated in this study between January 2019 and May 2019. Overall success rate was similar for the flexible tip bougie and the standard bougie. The flexible tip bougie tended to need less intubation attempts in more difficult airway scenarios. Time to intubation was less if using the flexible tip bougie compared to the standard bougie. Reduced severity of dental compression was noted for the flexible tip bougie in difficult airway scenarios except cervical collar stabilization. CONCLUSION:In this simulation study of normal and difficult airways scenarios, overall success rate was similar for the flexible tip and standard bougie. Especially in more difficult airway scenarios, less intubation attempts, and less optimization maneuvers were needed if using the flexible tip bougie. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT03733158. 7th November 2018.

Project description:BackgroundLidocaine (LDC) is a local anesthetic widely used to relieve intubation-related airway responses. However, low drug concentration and short effective duration of LDC is inadequate to provide a satisfactory anesthetic effect on the surface of the airway. The present study sought to develop a LDC-delivery endotracheal tube (ETT) to achieve high local drug concentration and sustained drug release with the aim of attenuating an intubation-related airway response.MethodsETTs and polyvinyl chloride (PVC) discs were coated with different molecular weight (MW) poly lactic-co-glycolic acid (PLGA: 50/50; MW: 3,000, 6,000, and 10,000) loaded with LDC by airbrush spray. The morphology of LDC-eluting coatings was analyzed using scanning electron microscopy. In vitro drug release was determined by ultraviolet spectrophotometer. An in vivo study was performed to investigate the differences in plasma LDC concentration, intubation tolerance, and tracheal tissue injury in rabbits undergoing intubation of blank, LDC-spray, or LDC-coated ETTs.ResultsApproximate 5 mg/cm2 coatings (containing 2.5 mg/cm2 LDC) were deposited onto the PVC discs and ETTs. While even distribution and smooth surfaces were generated in PLGA3000 + LDC and PLGA6000 + LDC coatings, PLGA10000 + LDC formed uneven and gullied coatings. Burst release within the first 4 h and sustained release for at least 5 days was achieved in vitro in PLGA + LDC coatings and the in vivo study demonstrated higher plasma LDC concentration and longer drug release duration in LDC-coated ETTs compared with LDC-spray. LDC-coated ETTs significantly improved intubation tolerance in rabbits, as measured by less general anesthetic consumption and longer tube tolerance duration in contrast to blank ETTs with or without LDC spray. Histology assessment showed less mucosal edema area in the PLGA3000 + LDC and PLGA6000 + LDC groups compared to the control, LDC-spray, and PLGA10000 + LDC groups. Among the different MW PLGAs, PLGA6000 presented optimal morphological characteristics, drug release, and anesthetic effect.ConclusionsETTs coated with PLGA + LDC effectively attenuate an intubation-related airway response via increasing local drug concentration and extending drug action duration, which demonstrates a potential therapeutic benefit for patients undergoing intubation.

Dataset Information

Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial.

Publications

Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial.

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