VCISpain: protocol for a prospective multicenter observational study to validate a standardized classification tool for tracheal intubation using videolaryngoscopy
VCISpain: protocolo para um estudo observacional prospectivo multicêntrico para validar uma ferramenta padronizada de classificação para intubação traqueal utilizando videolaringoscopia
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 em nome do VCISpain Trial Investigators Group
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).
Conclusion
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.
Keywords
Resumo
Introdução
A videolaringoscopia transformou o manejo das vias aéreas ao melhorar as taxas de sucesso na intubação em comparação com a laringoscopia direta. No entanto, sua ampla adoção tem sido dificultada pela falta de ferramentas padronizadas de classificação para documentação e comunicação. Este manuscrito descreve a justificativa e o desenho do estudo VCISpain, que tem como objetivo avaliar a reprodutibilidade interobservador da escala Video Classification of Intubation (VCI) no contexto do manejo das vias aéreas utilizando videolaringoscopia na Espanha.
Métodos
Este manuscrito apresenta a metodologia planejada para o estudo VCISpain, um estudo prospectivo, observacional, multicêntrico e de rótulo aberto. Serão coletados dados sobre intubações traqueais realizadas em salas de cirurgia, unidades de terapia intensiva e departamentos de emergência. Em cada caso, dois anestesiologistas aplicarão de forma independente a escala VCI para avaliar o tipo de lâmina, a Percentage of Glottic Opening (POGO) e a facilidade de intubação.
Ética e registro
O estudo foi aprovado pelo Comitê de Ética da Universidade de Navarra (2022.079 mod1) e registrado no ClinicalTrials.gov (NCT06537531). Conta com o apoio da Spanish Society of Anesthesiology, Resuscitation and Pain Therapy (SEDAR) e da European Airway Management Society (EAMS).
Conclusão
O VCISpain busca estabelecer uma ferramenta padronizada de classificação para documentar e comunicar achados relacionados à videolaringoscopia no manejo das vias aéreas. Ao apresentar a justificativa e o desenho do estudo, este protocolo visa promover a transparência, garantir rigor metodológico e incentivar uma discussão mais ampla para aperfeiçoar o estudo antes de sua implementação.
Palavras-chave
References
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Submitted date:
02/11/2025
Accepted date:
06/04/2025
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