Difficult Airway Simulation-based Training

June 12, 2023 updated by: Kateryna Bielka, Bogomolets National Medical University

Difficult Airway Simulation-based Training in Anaesthesiologists: Efficacy and Skills Retention Within Six Months After Training

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.

Study Overview

Detailed Description

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. We obtained consent from them to participate anonymously as volunteers. Before the first training, we interviewed all participants about their experience in working in the speciality, difficult airways management, learning at any simulation training and difficult airways training particularly.

The simulation room included a mannequin Laerdal SimMom Advanced Patient Simulator, vital monitor, anaesthesia station LEON and airway devices. Standard settings included modelling of tongue oedema to grade 4 visualizations on laryngoscopy according to the Cormack and Lehane classification, as well as additional pharyngeal obstruction and stiffness of both lungs for the "cannot ventilate" scenario. A standard set of tools and equipment for ensuring airway patency, ventilation and tracheal intubation included facemasks, oropharyngeal and nasal airways, laryngoscopes, laryngeal masks, and tracheal tubes in a range of sizes. The trolley for difficult airways was available for each station and was equipped with additional laryngoscope blades of various sizes, a video laryngoscope, laryngeal masks of various sizes (Igel), introducers for tracheal tubes (stylets and bougies), Airtraq, a cricotomy kit.

Monitoring provided SpO2, EtCO2, ECG and non-invasive blood pressure measurement. When the oxygen delivery was interrupted for 20 seconds or more, the SpO2 gradually decreased by 3% every 5 seconds and reached 90% after 20 seconds. A value of SpO2 < 90% was considered desaturation. Effective ventilation was defined after at least two effective breaths evidenced by an EtCO2 curve on the monitor.

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. Participants were expected to follow an algorithm according to the Difficult Airway Society (DAS) recommendations [4].

During the scenario, we recorded significant deviations from the DAS protocol and other indicators that impacted the quality of the algorithm execution. The primary endpoints included significant deviations from the DAS protocol: 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 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. The primary and secondary endpoints were compared between three rounds: initial simulation (Group 1), immediately after training (Group 2), and six months after training (Group 3).

Statistical analysis was performed using licensed Microsoft Office Excel and web source www.socscistatistics.com. We used Student's, Kruskal-Wallis and Fisher's exact tests. The difference was considered significant at α < 5% (p < 0.05).

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kyiv, Ukraine
        • Bogomolets NMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult anesthesiologists volunteers

Description

Inclusion Criteria:

Adult anesthesiologists volunteers

Exclusion Criteria:

Refusion to participate, age more than 70 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 3
Each volunteer went through two simulation scenarios of difficult airway management after 6 month
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant deviations from the DAS protocol
Time Frame: 2 hours
more than three laryngoscopy attempts
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other deviations from DAS protocol
Time Frame: 2 hours
use of bougie
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 4012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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