Clinical trial NCT03747250: Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia
Official title: Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation Morbidity
Keywords: Videolaryngoscopy
Laryngoscopy
Tracheal intubation
Success rate
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 501
Sex: ALL
Minimum age (years): 29
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.

Detailed description: Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled for elective surgery
* Planned tracheal intubation for airway management during surgery
* Signed informed consent

Exclusion Criteria:

* Emergency surgery
* Other airway management plan
* age outside the predefined limits
* Informed consent not signed

Primary outcomes:
measure: First intubation attempt success rate
timeFrame: Intraoperatively
Secondary outcomes:
measure: Time for successful intubation
timeFrame: Intraoperatively
measure: Overall intubation success rate
timeFrame: Intraoperatively
measure: Laryngeal view
timeFrame: Intraoperatively
measure: Complications
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno - FN Brno
state: Czech Republic
Study officials:
affiliation: KDAR FN Brno
name: Petr Štourač, assoc.Prof.MD.Ph.D
role: STUDY_CHAIR
References:
citation: Klabusayova E, Klucka J, Kosinova M, Toukalkova M, Stoudek R, Kratochvil M, Marecek L, Svoboda M, Jabandziev P, Urik M, Stourac P. Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Paediatric Anaesthesia: A prospective randomised controlled trial. Eur J Anaesthesiol. 2021 Nov 1;38(11):1187-1193. doi: 10.1097/EJA.0000000000001595.