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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videolaryngoscope group | Active Comparator | For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. |
|
| Direct laryngoscope group | Active Comparator | For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videolaryngoscope | Device | For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of tracheal intubation |
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Taboada Muñiz, Ph.D. | Contact | +34678195618 | manutabo@yahoo.es |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Taboada Muñiz | University Clinical Hospital of Santiago de Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A CORUÑA | 15706 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41046172 | Result | 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. |
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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.
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| Direct Laryngoscope | Device | For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. |
|
| Duration of procedure (minutes) |
| Number of laryngoscopy attempts | Number of laryngoscopy attempts | 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):
| Duration of procedure (minutes) |
| Operator-assessed difficulty of intubation | Operator-assessed difficulty of intubation
| 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 for additional airway equipment | Airway equipment: bougie, stylet, other videolaryngoscope, others. | 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) |
| From induction to 15 minutes following tracheal intubation |