VCISpain: Protocol for a prospective multicenter observational study to validate a standardized classification tool for tracheal intubation using videolaryngoscopy.

Miguel Ángel Fernández-Vaquero, Pedro Charco-Mora, Jose Alfonso Sastre-Rincon, Manuel Ángel Gomez-Rios, Johanes Cardenas-Gomez, Eugenio Martinez-Hurtado, Norma Aracil-Escoda, Andrea Vallejo-Tarrat, Inés Thion-Soriano, David Peral-Sanchez, Miguel Castañeda-Pascual, Miguel Rodriguez Del Rio, Nekari de Luis-Cabezon, Joseba Gonzalez-Garcia, Jesus Acosta-Martinez, Silvia Gonzalez-Santos, Xavier Onrubia-Fuertes, Estefania Martinez-Gonzalez, Andres Roca de Togores-Lopez, Iratxe Gonzalez-Mendibil, Almudena Baños-Maestro, Marisa Mariscal-Flores, Aitana Lluch-Oltra, Izaskun Emazabel-Yunta, Diana M Rodriguez-Sanabria, José Manuel Álvarez-Avello, Diego A Meléndez Salinas, Teresa Lopez-Correa, Miriam Sanchez-Merchante, Maria Bermudez-Lopez, Elena Martinez-Gallego, Maria C Martinez-Segovia, Ana Belen Martin-Andres, Yaiza Molero-Diez, Miguel A Garcia-Aroca, Blanca Tapia-Salinas, Jaume Puig-Bernabe, Andrea Piano, Gloria Hernandez-Fernandez, Alvaro Mingote-Lladó, Javier Garcia-Fernandez, Javier Mata-Estevez, Laura Reviriego-Agudo, Gabriel Ruiz-Cordoba, Javier Moya-Moradas, Francisco Javier Marques-Asin, Marc Vives Santacana
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Abstract

Background and objective: Videolaryngoscopy have transformed airway management by improving intubation success rates compared to direct laryngoscopy. However, its widespread adoption has been hindered by the lack of standardized classification tools for documentation and communication. This manuscript outlines the rationale and study design of the VCISpain project, which aims to evaluate the interobserver reproducibility of the Video Classification of Intubation (VCI) scale in the context of airway management using videolaryngoscopy in Spain.

Methods: This manuscript presents the planned methodology of the VCISpain study, a prospective, observational, multicenter, open-label study. The study will collect data on tracheal intubations performed in operating rooms, intensive care units, and emergency departments. In each case, two anesthesiologists will independently apply the VCI scale to assess blade type, Percentage of Glottic Opening (POGO), and ease of intubation.

Ethics and registration: The study was approved by the University of Navarra Ethics Committee (2022.079 mod1) and registered on ClinicalTrials.gov (NCT06537531). It is endorsed by the Spanish Society of Anesthesiology, Resuscitation and Pain Therapy (SEDAR) and the European Airway Management Society (EAMS).

Conclusions: VCISpain seeks to establish a standardized classification tool for documenting and communicating findings related to videolaryngoscopy in airway management. By presenting the study rationale and design, this protocol aims to promote transparency, ensure methodological rigor, and encourage broader discussion to refine the study prior to implementation.

VCISpain:一项前瞻性多中心观察性研究的方案,以验证使用视频喉镜进行气管插管的标准化分类工具。
背景与目的:与直接喉镜相比,视频喉镜通过提高插管成功率改变了气道管理。然而,由于缺乏用于文档和通信的标准化分类工具,它的广泛采用受到了阻碍。本文概述了VCISpain项目的基本原理和研究设计,该项目旨在评估在西班牙使用视频喉镜进行气道管理的背景下,视频插管分类(VCI)量表的观察者间可重复性。方法:本文介绍了VCISpain研究的计划方法,这是一项前瞻性、观察性、多中心、开放标签的研究。该研究将收集在手术室、重症监护病房和急诊科进行气管插管的数据。在每种情况下,两名麻醉师将独立应用VCI量表来评估刀片类型,声门打开百分比(POGO)和插管的便便性。伦理和注册:该研究已获得纳瓦拉大学伦理委员会(2022.079 mod1)的批准,并在ClinicalTrials.gov上注册(NCT06537531)。它得到了西班牙麻醉、复苏和疼痛治疗学会(SEDAR)和欧洲气道管理学会(EAMS)的认可。结论:VCISpain旨在建立一个标准化的分类工具,用于记录和交流与气道管理中视频喉镜检查相关的发现。通过介绍研究的基本原理和设计,本协议旨在提高透明度,确保方法的严谨性,并鼓励在实施前进行更广泛的讨论以完善研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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