NCT05913492

Brief Summary

Difficult airways remain a significant problem in anaesthesia, intensive care and emergency medicine. Simulation-based training gives better outcomes compared to non-simulation and non-intervention education. However, it remains unclear how long the acquired skills are retained and how often simulation training should repeat. The study aimed to investigate the efficacy and skills retention in training for difficult airway management in anaesthesiologists. After ethical committee approval, we conducted a prospective control study at the postgraduate Department of Surgery, Anaesthesiology and Intensive Therapy (Bogomolets National Medical University) from July to December 2022. Anaesthesiologists who applied for the continuous medical education course "Difficult airways management" were involved in the study. The simulation room included a mannequin Laerdal SimMom Advanced Patient Simulator, vital monitor, anaesthesia station LEON and airway devices. Each volunteer went through two simulation scenarios of difficult airway management: 1) "cannot intubate, can ventilate" (CI), 2) "cannot intubate, cannot ventilate" (CICV) with the assistance of the training centre operator. The primary endpoints included: more than three laryngoscopy attempts; supraglottic airway attempt missing; call for help skip; failure to initiate a surgical airway (for the CICV scenario). Secondary endpoints included: time to call for help; mean duration of desaturation; use of bougie; use of video laryngoscope (Airtraq); mean number of intubation attempts; improper usage of equipment of equipment, time to initiation of surgical airway preparation; time to initiation of surgical airway ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

May 15, 2023

Last Update Submit

June 12, 2023

Conditions

Keywords

difficult airwayssimulation training

Outcome Measures

Primary Outcomes (1)

  • Significant deviations from the DAS protocol

    more than three laryngoscopy attempts

    2 hours

Secondary Outcomes (1)

  • Other deviations from DAS protocol

    2 hours

Study Arms (3)

Group 1

Each volunteer went through two simulation scenarios of difficult airway management on the first time

Group 2

Each volunteer went through two simulation scenarios of difficult airway management after training in difficult airway management according to DAS guidelines, using the same equipment as during the simulation

Behavioral: Simulation training

Group 3

Each volunteer went through two simulation scenarios of difficult airway management after 6 month

Behavioral: Simulation training

Interventions

Each volunteer went through two simulation scenarios of difficult airway management: 1) "cannot intubate, can ventilate" (CI), 2) "cannot intubate, cannot ventilate" (CICV) with the assistance of the training centre operator. Following the first simulation round, volunteers were trained on the same day in difficult airway management according to DAS guidelines, using the same equipment as during the simulation. The participants repeated the simulation scenarios immediately after the training and six months later.

Group 2Group 3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult anesthesiologists volunteers

You may qualify if:

  • Adult anesthesiologists volunteers

You may not qualify if:

  • Refusion to participate, age more than 70 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bogomolets NMU

Kyiv, Ukraine

Location

Related Publications (1)

  • Bielka K, Kuchyn I, Fomina H, Khomenko O, Kyselova I, Frank M. Difficult airway simulation-based training for anaesthesiologists: efficacy and skills retention within six months. BMC Anesthesiol. 2024 Jan 31;24(1):44. doi: 10.1186/s12871-024-02423-x.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 22, 2023

Study Start

July 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Locations