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Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol

Authors :
Ana Pérez
Manuel Taboada
Marta Giné
Raquel García-Álvarez
Ana Estany-Gestal
Jorge Fernández
Olalla Vazquez
Azucena Pajares
Fernando Ramasco
Sara Martínez
Irene Vallejo
Pablo Rama-Maceiras
María Bermúdez
Mercedes Power
Inmaculada Fernández-Villa
Jose Luis Aguilera
Marta Carrió
Rafael Cabadas
Anxo Rubín
Mónica Mercedes Williams
Raquel Fernández-García
Angel Becerra
Francisco Javier García
María Cristina Iglesias
Rosaura María Santamarina
Sara Del Valle
Luisa María Charco
María Concepción Alonso
Inés María Rodríguez
Marina Varela
Jose Ignacio Hermoso
Marc Vives
Teresa Cabaleiro
Source :
BMJ Open, Vol 14, Iss 9 (2024)
Publication Year :
2024
Publisher :
BMJ Publishing Group, 2024.

Abstract

Introduction Compared with the operating room, tracheal intubations in the intensive care unit (ICU) are associated with worsened glottic view, decreased first-time success rate and increase in the technical difficulty of intubation and incidence of complications. Videolaryngoscopes (VLs) have been proposed to improve airway management, and while recent studies have confirmed that VLs improve intubation conditions in this patient population, there remains a lack of clarity regarding the selection between a standard Macintosh blade or a hyperangulated one, to determine which yields the best outcomes. The purpose of this study was to compare successful intubation on the first attempt with the Macintosh VL versus the hyperangulated VL during tracheal intubation in ICU patients. We hypothesise that tracheal intubation using the hyperangulated VL will improve the frequency of successful intubation on the first attempt.Methods and analysis The INtubation VIdeolaryngoscopy BLADE-ICU trial is a prospective, multicentre, open-label, interventional, randomised, controlled superiority study conducted in 29 ICUs in Spain. Patients will be randomly assigned in a 1:1 ratio to undergo intubation using a Macintosh VL (control group) or a hyperangulated VL (experimental group) for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcomes include the time to intubation, attempts for successful intubation, laryngoscopic vision assessed with the modified Cormack-Lehane scale, the need for adjuvant airway devices for intubation, difficulty assessed by the anaesthesiologist and complications during tracheal intubation. Enrolment began on 1 May 2024 and is expected to be completed in 2025.Ethics and dissemination The study protocol was approved on 29 February 2024, by the Ethics Committee of Galicia (CEImG, code No. 2024-031).The results will be submitted for publication in a peer-reviewed journal.Trial registration number NCT06322719.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
14
Issue :
9
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.3cbc933450824cfe8502c3b4d95591c4
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2024-086691