Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

NCT07495436 | Not Yet Recruiting

• 1 other identifier: VIDEOKIDS Trial
• Study Type: interventional
• Target: 5,562
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tracheal Intubation; Videolaryngoscopy; General Anesthesia; Difficult Airway Intubation

Keywords

tracheal intubation; videolaryngoscopy; laryngoscopy; Paediatric airway; Airway management; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of procedure of procedure (minutes)

Secondary Outcomes (11)

• Successful intubation

  Duration of procedure (minutes)

• Incidence of "easy intubation"

  Duration of procedure (minutes)

• Number of laryngoscopy attempts

  Duration of procedure (minutes)

• Number of attempts to cannulate the trachea with a bougie or an endotracheal tube

  Duration of procedure (minutes)

• Duration of tracheal intubation

  Duration of procedure (minutes)

Other Outcomes (1)

• Complications of tracheal intubation

  From induction to 15 minutes following tracheal intubation

Study Arms (2)

Videolaryngoscope group

ACTIVE COMPARATOR

For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.

Device: Videolaryngoscope

Direct laryngoscope group

ACTIVE COMPARATOR

For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.

Device: Direct Laryngoscope

Interventions

Videolaryngoscope DEVICE

For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.

Videolaryngoscope group

Direct Laryngoscope DEVICE

For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.

Direct laryngoscope group

Eligibility Criteria

• Age: 0 Days - 16 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A CORUÑA, 15706, Spain

Location

Related Publications (1)

• 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 RESULT

Study Officials

• Manuel Taboada Muñiz

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Taboada Muñiz, Ph.D.

CONTACT

+34678195618; manutabo@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)