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

Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation Morbidity
• Intervention / Treatment: Device: Videolaryngoscopy; Device: Direct laryngoscopy

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 Type: Interventional
• Enrollment (Actual): 501
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Brno, Czech Republic, Czechia, 62500
      • University Hospital Brno - FN Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Videolaryngoscopy; Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope	Device: Videolaryngoscopy; In experimental group (interventional group), patients will be intubated with the videolaryngoscope
Active Comparator: 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	Device: Direct laryngoscopy; In control group (active comparator group), patients will be intubated with the direct laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First intubation attempt success rate	Success rate of the first intubation attempt	Intraoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Study Chair: Petr Štourač, assoc.Prof.MD.Ph.D, KDAR FN Brno

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Laryngoscopy; Tracheal intubation; Success rate
• Other Study ID Numbers: KDAR FN Brno 2018/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No