Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

N/ANot Yet RecruitingNCT07495436

Hospital Clinico Universitario de Santiago5,562 enrolled

Overview

Tracheal intubation in paediatric patients is a high-risk procedure in which failure to achieve successful intubation on the first attempt is associated with an increased risk of complications, including hypoxaemia and airway trauma. Videolaryngoscopes have been increasingly adopted in clinical practice because they improve glottic visualisation; however, evidence of their benefit in paediatric patients remains inconsistent (1) The VIDEOKIDS trial is a large, pragmatic, international, multicentre, randomised controlled trial designed to compare videolaryngoscopy with direct laryngoscopy as the initial technique for tracheal intubation in paediatric patients undergoing surgery under general anaesthesia. The primary objective is to determine whether videolaryngoscopy increases the rate of successful intubation on the first attempt compared with direct laryngoscopy. (1) Koepp-Medina G, Lusardi AC, Di Fonzo B, et al. Videolaryngoscopy versus direct laryngoscopy for paediatric tracheal intubation: systematic review and meta-analysis. Br J Anaesth 2025;135:1486-98.

The purpose of this prospective, international, multicentre, randomised controlled trial is to compare videolaryngoscopy with direct laryngoscopy as the initial technique for tracheal intubation in paediatric patients undergoing elective surgery under general anaesthesia. We hypothesise that videolaryngoscopy will increase the frequency of successful intubation on the first attempt compared with direct laryngoscopy. Eligible patients aged 0 to 16 years requiring orotracheal intubation will be randomly assigned in a 1:1 ratio to videolaryngoscopy or direct laryngoscopy for the first intubation attempt. The specific device and blade type, as well as all aspects of peri-intubation management, including patient positioning, preoxygenation, and pharmacological agents, will be determined by 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. A mixed-effects logistic regression model will be used to account for centre-level variability and prespecified clinically relevant covariates. Current evidence in paediatric populations remains inconclusive, with recent meta-analyses showing no clear improvement in first-attempt success despite better glottic visualisation with videolaryngoscopy.¹ The trial is expected to enrol approximately 5,500 patients across 15 to 20 hospitals in multiple countries, including Spain and Latin America. Recruitment is planned to begin in October 2026.

Eligibility

Sex: ALLMin age: 0 DaysMax age: 16 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * Paediatric patients (age 0-16 years), * Undergoing elective or scheduled surgery under general anaesthesia requiring orotracheal intubation, * Planned tracheal intubation using either videolaryngoscopy or direct laryngoscopy as the initial technique, * Informed or general consent given, according to the relevant ethics committee statement,. Exclusion Criteria: * Known upper airway anatomical abnormalities or clinical conditions requiring a specific intubation technique (e.g., fibreoptic intubation), * Requirement for emergent tracheal intubation that does not allow adequate randomisation, * Refusal of parents or legal guardians to participate in the study.

Outcomes

Primary Outcomes

Number of intubations with successful tracheal intubation on the first attempt

The primary outcome is successful tracheal intubation on the first attempt, defined as placement of an endotracheal tube in the trachea following a single insertion of the laryngoscope blade into the mouth, without its removal.

Time frame: Duration of procedure of procedure (minutes)