Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-16
SponsorHospital Clinico Universitario de Santiago
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Videolaryngoscope
DeviceFor patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
Direct Laryngoscope
DeviceFor patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.
Treatment groups
5,562 Participants
are divided into 2 treatment groupsGroup A: Videolaryngoscope groupActive comparator 1 intervention
Group B: Direct laryngoscope groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Duration of procedure of procedure (minutes)Secondary outcomes
1
Successful intubation
Successful placement of a tube in the trachea
Time frame
Duration of procedure (minutes)2
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.
Time frame
Duration of procedure (minutes)3
Number of laryngoscopy attempts
Number of laryngoscopy attempts
Time frame
Duration of procedure (minutes)4
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
Time frame
Duration of procedure (minutes)Other outcomes
1
Complications of tracheal intubation
1. Hypoxemia (lowest oxygen saturation measured by pulse oximetry 80%-90%), 2. Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry \< 80%), 3. Severe bradycardia: 1. 0-3 months old: HR \< 80 bpm, 2. 4 months - 2 years: HR \< 60 bpm, 3. 2-10 years old: HR \< 40 bpm, 4. 10-16 years old: HR \< 30 bpm at least 1 minute, 4. Laryngospasm, 5. Bronchospasm, 6. Obstruction of tracheal tube, 7. Airway injuries (bleeding,...), 8. Dental injuries, 9. Can't intubate, can't oxygenate (CICO) situation, 10. Severe bradycardia/Cardiac arrest 11. Pulmonary aspiration 12. Pneumothorax/ pneumomediastinum
Time frame
From induction to 15 minutes following tracheal intubationSponsors and contacts
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Source ClinicalTrials.gov