Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

Official title

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

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.

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.

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.

Interventions

• 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.

Primary outcome measures

• Number of intubations with successful tracheal intubation on the first attempt [Time frame: Duration of procedure of procedure (minutes)]

Secondary outcome measures (11)

• Successful intubation [Time frame: Duration of procedure (minutes)]
• Incidence of "easy intubation" [Time frame: Duration of procedure (minutes)]
• Number of laryngoscopy attempts [Time frame: Duration of procedure (minutes)]
• Number of attempts to cannulate the trachea with a bougie or an endotracheal tube [Time frame: Duration of procedure (minutes)]
• Duration of tracheal intubation [Time frame: Duration of procedure (minutes)]
• Reason for failure to intubate on the first attempt [Time frame: Duration of procedure (minutes)]
• Operator-assessed difficulty of intubation [Time frame: Duration of procedure (minutes)]
• Glottic view assessed using the modified Cormack-Lehane classification [Time frame: Duration of procedure (minutes)]
• Glottic view assessed using the percentage of glottic opening (POGO score). [Time frame: Duration of procedure (minutes)]
• Need for additional airway equipment [Time frame: Duration of procedure (minutes)]
• Need to change the device for intubation [Time frame: Duration of procedure (minutes)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Spain · 1 center

• Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela

Publications

• Koepp-Medina G, Lusardi AC, Di Fonzo B, Huber M, Afshari A, Bonfiglio R, Zimmermann L, Bohnenblust V, Greif R, Vendt J, Riva T, Disma N, Fuchs A. Videolaryngoscopy versus direct laryngoscopy for paediatric tracheal intubation: a systematic review with meta-analysis and trial sequential analysis. Br J Anaesth. 2025 Nov;135(5):1486-1498. doi: 10.1016/j.bja.2025.07.094. Epub 2025 Oct 3. PMID 41046172

Identifiers

NCT: NCT07495436 · VIDEOKIDS Trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗