Tracheal IntubationVIDEOKIDSNCT07495436
Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery
A study testing Videolaryngoscope and Direct Laryngoscope in people with Tracheal Intubation and Videolaryngoscopy, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 16 hours
- Conditions the study is for
- Tracheal Intubation, Videolaryngoscopy, General Anesthesia
- What is being tested?
- Videolaryngoscope and Direct Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,562 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 16 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A CORUÑA, 15706
Manuel Taboada Muñiz, Ph.D., 0034 981950674, manutabo@yahoo.es
Jorge Fernández, M.D., 0034 678195618, manuel.taboada.muniz@sergas.es
About this study
Official title: 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.
Read the 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.
- Being tested
- Videolaryngoscope, Direct Laryngoscope
- Keywords
- tracheal intubation, videolaryngoscopy, laryngoscopy, Paediatric airway, Airway management, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
Direct LaryngoscopeDevice
For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope group | Active comparator | For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. Receives: 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. Receives: Device: Direct Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of procedure of procedure (minutes)
Secondary outcomes (11)
Successful intubation
Successful placement of a tube in the trachea
Measured: 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.
Measured: Duration of procedure (minutes)
Number of laryngoscopy attempts
Number of laryngoscopy attempts
Measured: 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
Measured: 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.
Measured: 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
Measured: Duration of procedure (minutes)
Operator-assessed difficulty of intubation
Operator-assessed difficulty of intubation
- without difficulty
- mild difficulty
- moderate difficulty
- severe difficulty
Measured: 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
Measured: 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.
Measured: Duration of procedure (minutes)
Need for additional airway equipment
Airway equipment: bougie, stylet, other videolaryngoscope, others.
Measured: 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...).
Measured: Duration of procedure (minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jun 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago
- Investigators
- Manuel Taboada Muñiz, Principal investigator, University Clinical Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495436
- Sponsor's protocol ID
- VIDEOKIDS Trial
- Acronym
- VIDEOKIDS
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 41046172
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopy Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery: The VIDEOKIDS Pragmatic Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT07495436
- Acronym / sponsor ID
- VIDEOKIDS / VIDEOKIDS Trial
- Keywords
- tracheal intubation, videolaryngoscopy, laryngoscopy, Paediatric airway, Airway management, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,562 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope group | Active comparator | Device: VideolaryngoscopeFor patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. |
| Direct laryngoscope group | Active comparator | Device: Direct LaryngoscopeFor patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. |
Who may qualify
- Ages
- 0 days to 16 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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,.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideolaryngoscopeFor patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. | Device | Videolaryngoscope group |
| Direct LaryngoscopeFor patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. | Device | Direct laryngoscope group |
Primary outcome
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.
11 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 41046172Koepp-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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manuel Taboada Muñiz principal investigator
University Clinical Hospital of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope and Direct Laryngoscope in people with Tracheal Intubation and Videolaryngoscopy, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel Taboada Muñiz, Ph.D. (+34678195618, manutabo@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intubations with successful tracheal intubation on the first attempt (time frame: Duration of procedure of procedure (minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.