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

NCT ID: NCT03747250

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-02-28

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.

Conditions

Tracheal Intubation Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Videolaryngoscopy

Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope

Group Type: EXPERIMENTAL

Videolaryngoscopy

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Direct laryngoscopy

Intervention Type: DEVICE

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

Interventions

Videolaryngoscopy

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

Intervention Type: DEVICE

Direct laryngoscopy

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 29 Days
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

assoc.prof.MD,Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Štourač, assoc.Prof.MD.Ph.D

Role: STUDY_CHAIR

KDAR FN Brno

Locations

University Hospital Brno - FN Brno

Brno, Czech Republic, Czechia

Countries

Czechia

References

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.

Reference Type: DERIVED

PMID: 34560686 (View on PubMed)

Other Identifiers

KDAR FN Brno 2018/12

Identifier Type: -

Identifier Source: org_study_id