NCT07495436

Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

Videolaryngoscopy Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery: The VIDEOKIDS Pragmatic Multicentre Randomized Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,562 (estimated)
• Sponsor: Hospital Clinico Universitario de Santiago · Academic / Other
• Sex: All
• Age: 0 Days – 16 Hours
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.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.

Conditions

• Tracheal Intubation
• Videolaryngoscopy
• General Anesthesia
• Difficult Airway Intubation

Interventions

Type	Name	Description
DEVICE	Videolaryngoscope	For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
DEVICE	Direct Laryngoscope	For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Spain