Skip to main content
OpenTrials
Completed

NCT Number: NCT03747250

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

29 day–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Brno - FN Brno

Brno, Czech Republic, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

videolaryngoscopy

Device

In experimental group (interventional group), patients will be intubated with the videolaryngoscope

direct laryngoscopy

Device

In control group (active comparator group), patients will be intubated with the direct laryngoscope

Primary outcomes

  1. First intubation attempt success rate

    Time frame: Intraoperatively

    Success rate of the first intubation attempt

Secondary outcomes

  1. Time for successful intubation

    Time frame: Intraoperatively

    Time need for intubation from decision to intubate to first end-tidal CO2 wave

  2. Overall intubation success rate

    Time frame: Intraoperatively

    Success rate fot intubation

  3. Laryngeal view

    Time frame: Intraoperatively

    Laryngeal view scored by Cormack-Lehane grading system

  4. Complications

    Time frame: Intraoperatively

    Incidence of associated complications during anesthesia induction - desaturation, bradycardia

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

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

Acronym: Videoscopy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2018
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.