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Not yet recruiting Not applicable NCT07495436

Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

No applicable phase (e.g. observational)
Conditions: Tracheal Intubation Videolaryngoscopy General Anesthesia Difficult Airway Intubation

Sponsor: Hospital Clinico Universitario de Santiago

trial.available_in: БГ
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. 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.
Description
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. The trial is expected to enrol approximately 5,600 patients across 15 to 25 hospitals in multiple countries, including Spain and Latin America. Recruitment is planned to begin in May 2026.
Who can participate
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.
Interventions
Videolaryngoscope
DEVICE
Direct Laryngoscope
DEVICE
Locations 1
Spain (1)
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela , A CORUÑA
Manuel Taboada Muñiz, Ph.D.
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
0 Days
Maximum age
16 Hours
Healthy volunteers
No
Start date
01.05.2026
Completion date
30.12.2027
Registry ID
NCT07495436
Source
clinicaltrials.gov
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