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

Study Overview
=================
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.

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

Conditions
-----------------
Tracheal Intubation Morbidity

Intervention / Treatment
-----------------
* Device: Videolaryngoscopy
* Device: Direct laryngoscopy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 29 Days
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videolaryngoscopy<br>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<br>* In experimental group (interventional group), patients will be intubated with the videolaryngoscope<br>|
| Active Comparator: Direct laryngoscopy<br>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<br>* In control group (active comparator group), patients will be intubated with the direct laryngoscope<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Videolaryngoscopy, Laryngoscopy, Tracheal intubation, Success rate