Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia

Not Applicable

Completed

• Conditions: Tracheal Intubation Morbidity
• Interventions: Device: Videolaryngoscopy; Device: Direct laryngoscopy

• Registration Number: NCT03747250
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Start: 2019-01-01
• Status Verified: 2020-02
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-28
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Videolaryngoscopy	Videolaryngoscopy	Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope
Direct laryngoscopy	Direct laryngoscopy	Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of direct laryngoscopy

Primary Outcome Measures

Name	Time	Method
First intubation attempt success rate	Intraoperatively	Success rate of the first intubation attempt

Secondary Outcome Measures

Name	Time	Method
Laryngeal view	Intraoperatively	Laryngeal view scored by Cormack-Lehane grading system
Overall intubation success rate	Intraoperatively	Success rate fot intubation
Complications	Intraoperatively	Incidence of associated complications during anesthesia induction - desaturation, bradycardia
Time for successful intubation	Intraoperatively	Time need for intubation from decision to intubate to first end-tidal CO2 wave

Trial Locations

Locations (1)

University Hospital Brno - FN Brno; 🇨🇿 Brno, Czech Republic, Czechia