Dataset Information

SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland.

ABSTRACT: Video-laryngoscopes are marketed for intubation in difficult airway management. They provide a better view of the larynx and may facilitate tracheal intubation, but there is no adequately powered study comparing different types of video-laryngoscopes in a difficult airway scenario or in a simulated difficult airway situation.The objective of this trial is to evaluate and to compare the clinical performance of three video-laryngoscopes with a guiding channel for intubation (Airtraq™, A. P. Advance™, King Vision™) and three video-laryngoscopes without an integrated tracheal tube guidance (C-MAC™, GlideScope™, McGrath™) in a simulated difficult airway situation in surgical patients. The working hypothesis is that each video-laryngoscope provides at least a 90% first intubation success rate (lower limit of the 95% confidence interval >0.9). It is a prospective, patient-blinded, multicenter, randomized controlled trial in 720 patients who are scheduled for elective surgery under general anesthesia, requiring tracheal intubation at one of the three participating hospitals. A difficult airway will be created using an extrication collar and taping the patients' head on the operating table to substantially reduce mouth opening and to minimize neck movement. Tracheal intubation will be performed with the help of one of the six devices according to randomization. Insertion success, time necessary for intubation, Cormack-Lehane grade and percentage of glottic opening (POGO) score at laryngoscopy, optimization maneuvers required to aid tracheal intubation, adverse events and technical problems will be recorded. Primary outcome is intubation success at first attempt.We will simulate the difficult airway and evaluate different video-laryngoscopes in this highly realistic and clinically challenging scenario, independently from manufacturers of the devices. Because of the sufficiently powered multicenter design this study will deliver important and cutting-edge results that will help clinicians decide which device to use for intubation of the expected and unexpected difficult airway.NCT01692535.

SUBMITTER: Theiler L

PROVIDER: S-EPMC3651724 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland.

Theiler Lorenz L Hermann Kristina K Schoettker Patrick P Savoldelli Georges G Urwyler Natalie N Kleine-Brueggeney Maren M Arheart Kristopher L KL Greif Robert R

Trials 20130404

<h4>Background</h4>Video-laryngoscopes are marketed for intubation in difficult airway management. They provide a better view of the larynx and may facilitate tracheal intubation, but there is no adequately powered study comparing different types of video-laryngoscopes in a difficult airway scenario or in a simulated difficult airway situation.<h4>Methods/design</h4>The objective of this trial is to evaluate and to compare the clinical performance of three video-laryngoscopes with a guiding chan ...[more]

PMID: 23556410

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Project description:Background and Objectives: Difficult intubation, which may be encountered unexpectedly during anesthesia, can increase patients' morbidity and mortality. The McGRATH video laryngoscope is known to provide improved laryngeal visibility in patients with difficult or normal airways. The purpose of this study was to evaluate the efficacy of the McGRATH video laryngoscope for orotracheal intubation compared with that of conventional Macintosh laryngoscopes in simulated difficult airway scenarios. Materials and Methods: In this randomized controlled trial, patients who were scheduled for surgery under general anesthesia requiring orotracheal intubation were assigned to the Macintosh laryngoscope (n = 50) or McGRATH video laryngoscope (n = 45) groups. In this study, to create a simulated difficult airway condition, the subjects performed manual in-line stabilization and applied a soft cervical collar. The primary outcome was the rate of successful intubation within 30 s. The time required for an intubation, glottis grade, intubation difficulty scale (IDS score), the subjective ease of intubation, and optimal external laryngeal manipulation (OLEM) were evaluated. In addition, complications caused by each blade were investigated. Results: The intubation success rate within 30 s was not significantly different between the two groups (44 (88.0%) vs. 36 (80.0%), p = 0.286). The glottic grade was better in the McGRATH group than in the Macintosh group (p = 0.029), but neither the intubation time (26.3 ± 8.2 s vs. 24.2 ± 5.0 s, p = 0.134) nor the rates of oral bleeding (2 (4.0%) vs. 0 (0.0%)) and tooth injury (0 (0.0%) vs. 1 (2.2%)) were significantly different between the two groups. Conclusions: The use of the McGRATH video laryngoscope did not improve the intubation success rate or shorten the intubation time. However, the McGRATH video laryngoscope provided a better glottis view than the conventional Macintosh laryngoscope in patients with a simulated difficult airway.

Project description:Difficult airways can be managed with a range of devices, with video laryngoscopes (VLs) being the most common. The C-MAC® Video-Stylet (VS; Karl-Storz Germany), a hybrid between a flexible and a rigid intubation endoscope, has been recently introduced. The aim of this study is to investigate the performance of the VS compared to a VL (C-MAC Macintosh blade, Karl-Storz Germany) with regards to the learning curve for each device and its ability to manage a simulated difficult airway manikin. This is a single-center, prospective, randomized, crossover study involving twenty-one anesthesia residents performing intubations on a Bill 1™ (VBM, Germany) airway manikin model. After a standardized introduction, six randomized attempts with VL and VS were performed on the manikin. This was followed by intubation in a simulated difficult airway (cervical collar and inflated tongue) with both devices in a randomized fashion. The primary end-point of this study was the total time to intubation. All continuous variables were expressed as the median [interquartile range] and analyzed using the Mann-Whitney U test. A 2-way ANOVA with Bonferroni's post hoc test was used to compare both devices at each trial. All reported p values are two sided. The median total time to intubation on a simulated difficult airway was faster with the VS compared to VL (17 [13.5-25] sec vs 23 [18.5-26.5] sec, respectively; 95% CI; P = 0.031). Additionally, on a normal airway manikin, the VS has a comparable learning curve to the VL. In this manikin-based study, the novel VS was comparable to the VL in terms of learning curve in a normal airway. In a simulated difficult airway, the total time to intubation, though likely not clinically relevant, was faster with the VS to the VL. However, given the above findings, this study justifies further human clinical trials with the VS to see if similar benefits-faster time to intubation and similar learning curve to VL-are replicated clinically.

Project description:OBJECTIVE:Video laryngoscopes are used for managing difficult airways. This study compared three video laryngoscopes' (Pentax-Airway Scope [Pentax], King Vision[King] and McGrath MAC [McGrath]) performances with the Macintosh direct laryngoscope (Macintosh) as emergency tracheal intubations (TIs) reference. DESIGN:Retrospective cohort study. SETTING:The emergency department (ED) and the intensive care unit (ICU) of two Japanese tertiary-level hospitals. PARTICIPANTS:All consecutive video-recorded emergency TI cases in EDs and ICUs between December 2013 and June 2015. PRIMARY OUTCOME MEASURES:The primary study endpoint was first-pass intubation success. A subgroup analysis examined the first-pass intubation success of expert versus non-expert operators. A logistic regression analysis was performed to identify the predictors of first-pass intubation success. RESULTS:A total of 287 emergency TIs were included. The first-pass intubation success rates were 78%, 58%, 78% and 58% for the Pentax, King, McGrath and Macintosh instruments, respectively (p=0.004, Fisher's exact test). The non-expert operators' success rates were significantly higher (p=0.00004, Fisher's exact test) for the Pentax (87%) and McGrath (78%) instruments than that for the King (50%) and Macintosh (46%) instruments, unlike that of the experts (67%, 67%, 78% and 78% for Pentax, McGrath, King and Macintosh, respectively; p=0.556, Fisher's exact test). After TI indication, difficult airway characteristics, and expert versus non-expert operator parameters adjustments, the Pentax (OR=3.422, 95% CI 1.551 to 7.550; p=0.002) and McGrath (OR= 3.758, CI 1.640 to 8.612; p=0.002) instruments showed significantly higher first-pass intubation success odds when compared with the Macintosh laryngoscope (reference, OR=1). The King instrument, however, (OR=1.056; 95% CI 0.487 to 2.289, p=0.889) failed to show any significant superiority. CONCLUSION:The Pentax and McGrath laryngoscopes showed significantly higher emergency TI first-pass intubation success rates than the King laryngoscope when compared with the Macintosh laryngoscope, especially for non-expert operators. TRIAL REGISTRATION NUMBER:UMIN000027925; Results.

Dataset Information

SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland.

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SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland.

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