Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients.
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ABSTRACT: Purpose
The effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear. We hypothesised that the first-attempt intubation success rate would be higher with tracheal tube + stylet than with tracheal tube alone.Methods
In this multicentre randomised controlled trial, conducted in 32 intensive care units, we randomly assigned patients to tracheal tube + stylet or tracheal tube alone (i.e. without stylet). The primary outcome was the proportion of patients with first-attempt intubation success. The secondary outcome was the proportion of patients with complications related to tracheal intubation. Serious adverse events, i.e., traumatic injuries related to tracheal intubation, were evaluated.Results
A total of 999 patients were included in the modified intention-to-treat analysis: 501 (50%) to tracheal tube + stylet and 498 (50%) to tracheal tube alone. First-attempt intubation success occurred in 392 patients (78.2%) in the tracheal tube + stylet group and in 356 (71.5%) in the tracheal tube alone group (absolute risk difference, 6.7; 95%CI 1.4-12.1; relative risk, 1.10; 95%CI 1.02-1.18; P = 0.01). A total of 194 patients (38.7%) in the tracheal tube + stylet group had complications related to tracheal intubation, as compared with 200 patients (40.2%) in the tracheal tube alone group (absolute risk difference, - 1.5; 95%CI - 7.5 to 4.6; relative risk, 0.96; 95%CI 0.83-1.12; P = 0.64). The incidence of serious adverse events was 4.0% and 3.6%, respectively (absolute risk difference, 0.4; 95%CI, - 2.0 to 2.8; relative risk, 1.10; 95%CI 0.59-2.06. P = 0.76).Conclusions
Among critically ill adults undergoing tracheal intubation, using a stylet improves first-attempt intubation success.
SUBMITTER: Jaber S
PROVIDER: S-EPMC8144872 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
| S-EPMC7542923 | biostudies-literature
Project description: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.
| S-EPMC6134434 | biostudies-literature
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
| S-EPMC8655668 | biostudies-literature
Project description:BACKGROUND:For critically ill patients, effective airway management with a high first-attempt success rate for endotracheal intubation is essential to prevent hypoxic complications during securing of the airway. Video guidance may improve first-attempt success rate over direct laryngoscopy (DL). METHODS:With ethics approval, this randomised controlled trial involved 54 critically ill patients who received endotracheal intubation using a tube with an integrated video camera (VivaSight™-SL tube, VST, ETView Ltd., Misgav, Israel) or using conventional intubation under DL. RESULTS:The two groups did not differ in terms of intubation conditions. The first-attempt success rate was VST 96% vs. DL 93% (not statistically significant (n. s.)). When intubation at first attempt failed, it was successful in the second attempt in all patients. There was no difference in the median average time to intubation (VST 34 s (interquartile range 28-39) vs. DL 35 s (28-40), n. s.). Neither vomiting nor aspiration or accidental oesophageal intubation were observed in either group. The lowest pulsoxymetric oxygen saturation for VST was 96 (82-99) % vs. 99 (95-100) % for DL (n. s.). Hypotension defined as systolic blood pressure?<?70 mmHg occurred in the VST group at 20% vs. the DL group at 15% (n. s.). CONCLUSION:In this pilot study, no advantage was shown for the VST. The VST should be examined further to identify patient groups that could benefit from intubation with the VST, that is, patients with difficult airway conditions. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02837055 . Registered on 13 June 2016.
| S-EPMC6151025 | biostudies-literature
Project description:BACKGROUND: Endotracheal intubation (ETI) is an essential skill that emergency medicine residents learn throughout their training. OBJECTIVE: To evaluate the effect of implementing a postgraduate year (PGY)-1 anesthesiology rotation on ETI success in the emergency department during PGY-2. METHODS: Residents in the study group completed a 4-week PGY-1 anesthesiology rotation. During the first 6 months of PGY-2, we compared ETI performance of the study group with a control group who did not experience a PGY-1 anesthesiology rotation. Data recorded included date, level of training, first- and second-attempt success, rescue devices used, major adverse events, and intubation scenario. A Pearson χ(2) test was used to compare first-attempt success, overall success (≤2 attempts), and adverse events rates between the 2 groups. RESULTS: Overall success rate for the study groups was 95.7% (111 of 116), compared with 94.5% (137 of 145) for the controls (P = 66). First-attempt success for the study group was 78.4% (91 of 116), compared with 83.4% (121 of 145) for the control group; this was not statistically significant (P = .30). Observed major and minor adverse events were similar: 19.0% for the study group (22 of 116) versus 24.8% (36 of 145) for the control group (P = .26). CONCLUSIONS: The addition of an anesthesiology rotation to the PGY-1 curriculum did not have a significant effect on ETI success or the rate of adverse events during the first 6 months of PGY-2. First-attempt overall success and adverse events of our PGY-2 study group were consistent with previously published studies.
| S-EPMC3613322 | biostudies-other
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.
| S-EPMC8184491 | biostudies-literature
Project description:ObjectiveTo determine which bedside method of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity.DesignProspective randomised blinded study.SettingDepartment of anaesthesia in tertiary academic hospital.Participants160 consecutive patients (American Society of Anesthesiologists category I or II) aged 19-75 scheduled for elective gynaecological or urological surgery.InterventionsPatients were randomly assigned to eight study groups. In four groups, an endotracheal tube was fibreoptically positioned 2.5-4.0 cm above the carina, whereas in the other four groups the tube was positioned in the right mainstem bronchus. The four groups differed in the bedside test used to verify the position of the endotracheal tube. To determine whether the tube was properly positioned in the trachea, in each patient first year residents and experienced anaesthetists were randomly assigned to independently perform bilateral auscultation of the chest (auscultation); observation and palpation of symmetrical chest movements (observation); estimation of the position of the tube by the insertion depth (tube depth); or a combination of all three (all three).Main outcome measuresCorrect and incorrect judgments of endotracheal tube position.Results160 patients underwent 320 observations by experienced and inexperienced anaesthetists. First year residents missed endobronchial intubation by auscultation in 55% of cases and performed significantly worse than experienced anaesthetists with this bedside test (odds ratio 10.0, 95% confidence interval 1.4 to 434). With a sensitivity of 88% (95% confidence interval 75% to 100%) and 100%, respectively, tube depth and the three tests combined were significantly more sensitive for detecting endobronchial intubation than auscultation (65%, 49% to 81%) or observation(43%, 25% to 60%) (P<0.001). The four tested methods had the same specificity for ruling out endobronchial intubation (that is, confirming correct tracheal intubation). The average correct tube insertion depth was 21 cm in women and 23 cm in men. By inserting the tube to these distances, however, the distal tip of the tube was less than 2.5 cm away from the carina (the recommended safety distance, to prevent inadvertent endobronchial intubation with changes in the position of the head in intubated patients) in 20% (24/118) of women and 18% (7/42) of men. Therefore optimal tube insertion depth was considered to be 20 cm in women and 22 cm in men.ConclusionLess experienced clinicians should rely more on tube insertion depth than on auscultation to detect inadvertent endobronchial intubation. But even experienced physicians will benefit from inserting tubes to 20-21 cm in women and 22-23 cm in men, especially when high ambient noise precludes accurate auscultation (such as in emergency situations or helicopter transport). The highest sensitivity and specificity for ruling out endobronchial intubation, however, is achieved by combining tube depth, auscultation of the lungs, and observation of symmetrical chest movements.Trial registrationNCT01232166.
| S-EPMC2977961 | biostudies-literature
Project description:IntroductionNeonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.Methods and analysisThe Stabilisation with nasal High flow during Intubation of NEonates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks' gestation; ≥28 weeks' gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).Ethics and disseminationThe SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women's Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.Trial registration numberACTRN12618001498280.
| S-EPMC7537449 | biostudies-literature
Project description:ObjectiveAdvancement of the endotracheal tube through a fibreoptic scope can sometimes prove to be challenging in obese patients. The Parker Flex-Tip endotracheal tube was developed with a curved and tapered distal tip to facilitate easier placement in the trachea. This study examined the use of the Parker Flex-Tip tube as compared to standard endotracheal tubes in patients with a body mass index of 30 or greater.MethodsSixty patients undergoing surgery requiring general anaesthesia were randomised into two groups. Using the fibreoptic scope, one group was intubated with the Parker Flex-Tip tube and the other group with a standard polyvinyl Portex tube. The time for intubation and the number of attempts required to place the endotracheal tube were measured and recorded.ResultsUsing the Mann-Whitney U rank sum test, the median time needed for intubation with the two types of endotracheal tubes did not show a significant difference. The chi-square analyses were conducted for the number of attempts needed to place the endotracheal tubes, which also did not demonstrate any significant difference.ConclusionsParker Flex-Tip endotracheal tube was not superior to the standard endotracheal tubes for fibreoptic intubation in obese patients.
| S-EPMC6756311 | biostudies-literature
Project description:IntroductionThe Covid-19 pandemic has required new protocols for endotracheal intubation mandating cumbersome personal protective equipment and modifications to prior intubation procedures. We assessed the success and complications of endotracheal intubation under such protocols.MethodsWe conducted a prospective study of endotracheal intubation in the emergency department, intensive care unit, or ward between September 11, 2018 and June 11, 2020 at two urban hospitals. Using a standardized form, we included basic demographics, intubation techniques, and success, and pre-specified complications, defined as critical (cardiac arrest or failure to intubate) or non-critical. At both sites, Covid-19 intubation protocols took effect on March 11, 2020, and we compared pre-post patients. The primary outcome was first-pass success without complications. Secondary outcomes included first-pass success and complications. We analysed by descriptive techniques.ResultsOverall, we collected 1534 patients before March 11, 2020 and 227 after; groups were similar in age and sex distribution. Staff endotracheal intubation increased from 37 to 63%. First pass success was 1262/1534 (82.3%) pre versus 195/227 (85.9%) post, for a difference of 3.6% (95% CI - 1.8-8.0%). First pass success without complications was 1116/1534 (72.8%) pre versus 168/227 (74.0%) post, for a difference of 1.3%, (95% CI - 5.2-7.0%). There were 226 complications pre (14.7%) versus 47 (20.7%) post, for a difference of 6.0%. (95% CI 0.6-12.1%).ConclusionsNew pandemic endotracheal intubation protocols did not result in a decrease in first-pass success, or first-pass success without complications.
| S-EPMC7798372 | biostudies-literature