Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery (VIDEOKIDS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: General Anesthesia; Tracheal Intubation; Videolaryngoscopy; Difficult Airway Intubation
• Intervention / Treatment: Device: Videolaryngoscope; Device: Direct Laryngoscope

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.

• Study Type: Interventional
• Enrollment (Estimated): 5562
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Taboada Muñiz, Ph.D.; Phone Number: +34678195618; Email: manutabo@yahoo.es

Study Locations

• Spain
  • A CORUÑA
    • Santiago de Compostela, A CORUÑA, Spain, 15706
      • Hospital Clínico Universitario de Santiago de Compostela
      • Contact: Manuel Taboada Muñiz, Ph.D.; Phone Number: 0034 981950674; Email: manutabo@yahoo.es
      • Contact: Jorge Fernández, M.D.; Phone Number: 0034 678195618; Email: manuel.taboada.muniz@sergas.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Videolaryngoscope group; For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.	Device: Videolaryngoscope; For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
Active Comparator: Direct laryngoscope group; For patients assigned to the laryngoscope Group, the operator will use a Macintosh 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of laryngoscopy attempts	Number of laryngoscopy attempts	Duration of procedure (minutes)
Need for additional airway equipment	Airway equipment: bougie, stylet, other videolaryngoscope, others.	Duration of procedure (minutes)
Successful intubation	Successful placement of a tube in the trachea	Duration of procedure (minutes)
Incidence of "easy intubation"	Easy intubation is defined as a patient with modified Cormack-Lehane I-IIa glottic view and intubation on the first attempt.	Duration of procedure (minutes)
Number of attempts to cannulate the trachea with a bougie or an endotracheal tube	Number of attempts to cannulate the trachea with a bougie or an endotracheal tube	Duration of procedure (minutes)
Duration of tracheal intubation	The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of an endotracheal tube in the trachea.	Duration of procedure (minutes)
Reason for failure to intubate on the first attempt	Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt): Inadequate view of the larynx; Inability to intubate the trachea with an endotracheal tube; Inability to cannulate the trachea with a bougie; Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding); Technical failure of the laryngoscope (e.g., battery, light source, camera, screen); Other	Duration of procedure (minutes)
Operator-assessed difficulty of intubation	Operator-assessed difficulty of intubation; without difficulty; mild difficulty; moderate difficulty; severe difficulty	Duration of procedure (minutes)
Glottic view assessed using the modified Cormack-Lehane classification	Modified Cormack-Lehane grade of glottic view: I: full view of the glottis, IIa: partial view of the glottis, IIb: arytenoid or posterior part of the vocal cords just visible, III: only epiglottis visible, IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view	Duration of procedure (minutes)
Glottic view assessed using the percentage of glottic opening (POGO score).	The Percentage of Glottic Opening (POGO) score is defined as the percentage (0% to 100%) of the glottic opening visualised during laryngoscopy, from the anterior commissure to the interarytenoid notch. A score of 0% indicates that no glottic structures are visible, whereas 100% indicates full visualisation of the glottis.	Duration of procedure (minutes)
Need to change the device for intubation	Need to replace by another device, a different angled blade, requirement for a fiberoptic bronchoscope...).	Duration of procedure (minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of tracheal intubation	Hypoxemia (lowest oxygen saturation measured by pulse oximetry 80%-90%),; Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry < 80%),; Severe bradycardia:0-3 months old: HR < 80 bpm,4 months - 2 years: HR < 60 bpm,2-10 years old: HR < 40 bpm,10-16 years old: HR < 30 bpm at least 1 minute,; Laryngospasm,; Bronchospasm,; Obstruction of tracheal tube,; Airway injuries (bleeding,...),; Dental injuries,; Can't intubate, can't oxygenate (CICO) situation,; Severe bradycardia/Cardiac arrest; Pulmonary aspiration; Pneumothorax/ pneumomediastinum	From induction to 15 minutes following tracheal intubation

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago
• Investigators: Principal Investigator: Manuel Taboada Muñiz, University Clinical Hospital of Santiago de Compostela

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomised controlled trial; laryngoscopy; Airway management; tracheal intubation; videolaryngoscopy; Paediatric airway
• Other Study ID Numbers: VIDEOKIDS Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be routinely shared due to regulatory and data protection restrictions across participating countries. Data access may be considered on a case-by-case basis, subject to applicable regulations and approval by the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No