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Intubation; Difficult or FailedNCT05913492

Difficult Airway Simulation-based Training

An observational study of Intubation; Difficult or Failed and Educational Problems, run by Bogomolets National Medical University at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Simulation training
How many people
67 participants
Where
1 siteUkraine
Study dates
1 Jul 2022to 1 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult anesthesiologists volunteers

Who may be able to join

  • Adult anesthesiologists volunteers

Who cannot join

  • Refusion to participate, age more than 70 years

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Bogomolets NMU

    Kyiv

Other trials in Ukraine

About this study

Official title: 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.

Read the 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).

Being tested
Simulation training
Keywords
difficult airways, simulation training
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation trainingBehavioural

    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.

Study groups in NCT05913492
Study groupRoleWhat they receive
Group 1Each volunteer went through two simulation scenarios of difficult airway management on the first time
Group 2Each 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
Receives: Behavioral: Simulation training
Group 3Each volunteer went through two simulation scenarios of difficult airway management after 6 month
Receives: Behavioral: Simulation training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Significant deviations from the DAS protocol

    more than three laryngoscopy attempts

    Measured: 2 hours

Secondary outcomes (1)
  1. Other deviations from DAS protocol

    use of bougie

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start1 Jul 2022
  3. Primary completion31 Dec 2022
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913492
Sponsor's protocol ID
4012
Status last verified
Jun 2023
First submitted
15 May 2023
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 38297196

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation; Difficult or Failed and Educational Problems, run by Bogomolets National Medical University at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Significant deviations from the DAS protocol (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05913492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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