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

Tracheal Intubation Morbidity Clinical Trial

— Videoscopy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747250
• Other study ID #: KDAR FN Brno 2018/12
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2020
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: February 28, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Tracheal Intubation Morbidity

Intervention

Device:
• Videolaryngoscopy
In experimental group (interventional group), patients will be intubated with the videolaryngoscope
• Direct laryngoscopy
In control group (active comparator group), patients will be intubated with the direct laryngoscope

Locations

Country	Name	City	State
Czechia	University Hospital Brno - FN Brno	Brno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First intubation attempt success rate	Success rate of the first intubation attempt	Intraoperatively
Secondary	Time for successful intubation	Time need for intubation from decision to intubate to first end-tidal CO2 wave	Intraoperatively
Secondary	Overall intubation success rate	Success rate fot intubation	Intraoperatively
Secondary	Laryngeal view	Laryngeal view scored by Cormack-Lehane grading system	Intraoperatively
Secondary	Complications	Incidence of associated complications during anesthesia induction - desaturation, bradycardia	Intraoperatively