- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05913492
Difficult Airway Simulation-based Training
Difficult Airway Simulation-based Training in Anaesthesiologists: Efficacy and Skills Retention Within Six Months After Training
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Kyiv, Ukraine
- Bogomolets NMU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult anesthesiologists volunteers
Exclusion Criteria:
Refusion to participate, age more than 70 years
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.