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

NCT03747250 | Completed DMC

• 1 other identifier: KDAR FN Brno 2018/12
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Intubation Morbidity

Keywords

Videolaryngoscopy; Laryngoscopy; Tracheal intubation; Success rate

Outcome Measures

Primary Outcomes (1)

• First intubation attempt success rate

  Success rate of the first intubation attempt

  Intraoperatively

Secondary Outcomes (4)

• Time for successful intubation

  Intraoperatively

• Overall intubation success rate

  Intraoperatively

• Laryngeal view

  Intraoperatively

• Complications

  Intraoperatively

Study Arms (2)

Videolaryngoscopy

EXPERIMENTAL

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

Direct laryngoscopy

ACTIVE COMPARATOR

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

Interventions

Videolaryngoscopy DEVICE

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

Videolaryngoscopy

Direct laryngoscopy DEVICE

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

Direct laryngoscopy

Eligibility Criteria

• Age: 29 Days - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients scheduled for elective surgery
• Planned tracheal intubation for airway management during surgery
• Signed informed consent

You may not qualify if:

• Emergency surgery
• Other airway management plan
• age outside the predefined limits
• Informed consent not signed

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno - FN Brno

Brno, Czech Republic, 62500, Czechia

Location

Related Publications (1)

• 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.

  PMID: 34560686 DERIVED

Study Officials

• Petr Štourač, assoc.Prof.MD.Ph.D

  KDAR FN Brno

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The allocation to the group will be randomized in located in closed envelope, that will be opened in the operating theater before anesthesia induction
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc.prof.MD,Ph.D

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: February 28, 2021
• Last Updated: March 23, 2021

Record last verified: 2020-02

Locations

CZ (1)