Scientific publications
Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol. Scientific Publication
Manuel Taboada 1 , Ana Estany-Gestal 2 , Jorge Fernández 3 , Olalla Vazquez 4 , Azucena Pajares 5 , Fernando Ramasco 6 , Sara Martínez 7 , Irene Vallejo 8 , Ana Pérez 9 , Pablo Rama-Maceiras 10 , María Bermúdez 11 , Mercedes Power 12 , Raquel García-Álvarez 13 , Inmaculada Fernández-Villa 14 , Jose Luis Aguilera 15 , Marta Carrió 16 , Rafael Cabadas 17 , Anxo Rubín 18 , Mónica Mercedes Williams 19 , Raquel Fernández-García 20 , Angel Becerra 21 , Marta Giné 22 , Francisco Javier García 23 , María Cristina Iglesias 24 , Rosaura María Santamarina 25 , Sara Del Valle 26 , Luisa María Charco 27 , María Concepción Alonso 28 , Inés María Rodríguez 29 , Marina Varela 30 , Jose Ignacio Hermoso 31 , Marc Vives 32 , Teresa Cabaleiro 33
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.
CITATION BMJ Open. 2024 Sep 5;14(9):e086691. doi: 10.1136/bmjopen-2024-086691.
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