Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol.
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Taboada Manuel, Estany-Gestal Ana, Fernández Jorge, Vazquez Olalla, Pajares Azucena, Ramasco Fernando, Martínez Sara, Vallejo Irene, Pérez Ana, Rama-Maceiras Pablo, Bermúdez María, Power Mercedes, García-Álvarez Raquel, Fernández-Villa Inmaculada, Aguilera Jose Luis, Carrió Marta, Cabadas Rafael, Rubín Anxo, Williams Mónica Mercedes, Fernández-García Raquel, Becerra Angel, Giné Marta, García Francisco Javier, Iglesias María Cristina, Santamarina Rosaura María, Del Valle Sara, Charco Luisa María, Alonso María Concepción, Rodríguez Inés María, Varela Marina, Hermoso Jose Ignacio, Vives Marc, Cabaleiro Teresa
Аннотация
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.