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NCT Number: NCT07495436

Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

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.

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Key information

Conditions

Tracheal Intubation Difficult Airway Intubation General Anesthesia Videolaryngoscopy

Age range

0 day–16 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Videolaryngoscope

Device

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

Direct Laryngoscope

Device

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

Primary outcomes

  1. Number of intubations with successful tracheal intubation on the first attempt

    Time frame: Duration of procedure of procedure (minutes)

    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.

Secondary outcomes

  1. Successful intubation

    Time frame: Duration of procedure (minutes)

    Successful placement of a tube in the trachea

  2. Incidence of "easy intubation"

    Time frame: Duration of procedure (minutes)

    Easy intubation is defined as a patient with modified Cormack-Lehane I-IIa glottic view and intubation on the first attempt.

  3. Number of laryngoscopy attempts

    Time frame: Duration of procedure (minutes)

    Number of laryngoscopy attempts

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

    Time frame: Duration of procedure (minutes)

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

  5. Duration of tracheal intubation

    Time frame: Duration of procedure (minutes)

    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.

  6. Reason for failure to intubate on the first attempt

    Time frame: Duration of procedure (minutes)

    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

  7. Operator-assessed difficulty of intubation

    Time frame: Duration of procedure (minutes)

    Operator-assessed difficulty of intubation

    • without difficulty
    • mild difficulty
    • moderate difficulty
    • severe difficulty

  8. Glottic view assessed using the modified Cormack-Lehane classification

    Time frame: Duration of procedure (minutes)

    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

  9. Glottic view assessed using the percentage of glottic opening (POGO score).

    Time frame: Duration of procedure (minutes)

    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.

  10. Need for additional airway equipment

    Time frame: Duration of procedure (minutes)

    Airway equipment: bougie, stylet, other videolaryngoscope, others.

  11. Need to change the device for intubation

    Time frame: Duration of procedure (minutes)

    Need to replace by another device, a different angled blade, requirement for a fiberoptic bronchoscope...).

Other outcomes

  1. Complications of tracheal intubation

    Time frame: From induction to 15 minutes following 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

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Taboada Muñiz, Ph.D.

CONTACT

[email protected]

+34678195618

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Registry information

Official study title

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

Acronym: VIDEOKIDS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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