Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in paediatric surgery: the VIDEOKIDS pragmatic international multicentre randomised trial study protocol
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Introduction Tracheal intubation in paediatric patients is a fundamental procedure in anaesthesia practice. Failure to achieve successful intubation on the first attempt is associated with an increased risk of complications, including hypoxaemia and airway trauma. Videolaryngoscopy has been proposed to improve glottic visualisation and facilitate tracheal intubation; however, current evidence in paediatric patients remains inconsistent and largely derived from small or highly selected populations. The purpose of this study is to compare successful intubation on the first attempt using videolaryngoscopy versus direct laryngoscopy during tracheal intubation in paediatric patients undergoing surgery. We hypothesise that videolaryngoscopy will increase the frequency of successful intubation on the first attempt. Methods and analysis The VIDEOKIDS trial is a prospective, international, multicentre, open-label, randomised controlled trial designed to compare videolaryngoscopy with direct laryngoscopy for tracheal intubation in paediatric patients undergoing general anaesthesia. Eligible patients aged 0–16 years requiring orotracheal intubation for elective or urgent surgery will be randomly assigned in a 1:1 ratio to videolaryngoscopy or direct laryngoscopy for the first intubation attempt. The choice of device brand and peri-intubation management, including patient positioning, preoxygenation strategy and pharmacological agents, will be left to the discretion of the attending anaesthesiologist according to local practice. The primary outcome is successful tracheal intubation on the first attempt. Secondary outcomes include time to intubation, number of intubation attempts, glottic visualisation, need for adjunct airway devices and intubation-related complications. The primary analysis will follow the intention-to-treat principle and will be unadjusted. A mixed-effects logistic regression model will be used as a sensitivity analysis to account for centre-level variability and prespecified clinically relevant covariates, including age group. The trial is expected to be conducted in approximately 20–25 hospitals across six countries: Spain, Portugal, Uruguay, Mexico, Colombia and Brazil. Enrolment began in May 2026 and is expected to be completed in December 2027. Ethics and dissemination The study protocol was approved in March 2026 by the Ethics Committee of Galicia (CEImG, code No. 2026/168). The results of this trial will be disseminated through presentations at scientific conferences and publication in a peer-reviewed journal. Trial registration number NCT07495436.
Source: BMJ Open
Authors: Manuel Taboada, Patricia Doldán, Jorge Fernández, Olalla Vazquez, María Doniz, Patricio González- Pizarro, Ana Peleteiro, Sonia Garcés-Sánchez, Cristina González, Vinicius Quintao, Marta Diéguez, María Bermúdez, Nekane García, Raquel Callejas, Jesús Oro, Juan Pablo Nocete, Antonio M González, José María Ahijado, Alfonso Fernández, Leidy Mar De Abreu Graterol, Florencia Galarraga, Lina Sarmiento, Natalia Puerto Tchemodanova, Alfonso Ernesto Albornoz, Jorge Pelicano Paulos, Dora Olveira, Patricia Santos, Ana Estany-Gestal, Teresa Cabaleiro-Ocampo, Teresa Seoane-Pillado
Institutions: Complejo Hospitalario Universitario de Santiago, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañón, Hospital Universitari i Politècnic La Fe, Donostiako Unibertsitate Ospitalea, Hospital Universitário da Universidade de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Complexo Hospitalario Universitario A Coruña, Hospital Universitario Lucus Augusti, Hospital Clínico Universitario de Valencia, Clinica Universidad de Navarra, Hospital Universitario Miguel Servet, Hospital Universitario 12 De Octubre, Marqués de Valdecilla University Hospital, Hospital Infantil Universitario Niño Jesús, Hospital Universitario Virgen del Rocío, Hospital Universitario Son Espases, Centro Hospitalario Pereira Rossell, Instituto Nacional de Pediatria, Hospital for Sick Children, Unidade Local de Saúde de São José, Hospital de São José, Hospital de Dona Estefânia, Unidade Local de Saúde de Coimbra, Hospital de São João, Universidade da Coruña
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W7222357073