Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance

NCT04743440 | Completed DMC

• 1 other identifier: bronchoscope-sad-performance
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study with the primary objective is to assess technical competence in anaesthesiology specialists who perform bronchoscopic endotracheal intubation through a supraglottic airway device (SAD), by using a global rating assessment scale (GRS) and a procedure checklist. We will use an Objective Structured Assessment of Technical Skills (OSATS)-inspired GRS that previously have been validated for fiberoptic intubation and a novel clinical checklist developed for the procedure. Secondarily, we will examine potential predictor variables.

Conditions

Airway Morbidity

Outcome Measures

Primary Outcomes (1)

• Physician performance

  Overall median physician performance score using an Objective Structured Assessment of Technical Skills (OSATS)-inspired validated global rating scale (GRS)

  6 months

Secondary Outcomes (5)

• Checklist score

  6 months

• Pass rate

  6 months

• Self-reported confidence

  6 months

• GRS score progression

  6 months

• interrater-agreement for GRS evaluation

  6 months

Other Outcomes (3)

• Time to intubation

  6 months

• Predictors for GRS scores

  6 months

• Predictors for time to intubation

  6 months

Study Arms (1)

Physicians

We will include specialists in anaesthesiology who work at the Anaesthesiology Department, Hillerød hospital, during the trial period. It is an inclusion criterion that they take part in the Anaesthesiology Department's specialist in-house on-call rotation (i.e., attending physician). Each of the included physician participants will be responsible for conducting the airway management in four patient participants; two who have been randomised to the i-gelTM LMA, and two to the Ambu® AuraGainTM LMA, respectively.

Device: Bronchoscopic endotracheal intubation through a supraglottic airway device

Interventions

Bronchoscopic endotracheal intubation through a supraglottic airway device DEVICE

Prior to trial commencement, participants will be asked to watch a video demonstrating preparation and conduction of the procedure (bronchoscopic endotracheal intubation through a supraglottic airway device) in a patient not involved in the project. Afterwards they will submit an online test, examining knowledge of the procedure relating to the procedure checklist. After participants have watched the demonstration video and submitted the online test, trial investigator will demonstrate the procedure in the manikin; subsequently, they have the opportunity to train the procedure in the manikin with both Igel and Auragain - training estimated to take less than 30 minutes. Afterwards, they will have the opportunity to train the procedure on manikins, on their own discretion, as per usual standards for maintaining airway competence at the Anaesthesiology Department.

Physicians

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anaesthetist specialists.It is an inclusion criterion that they take part in the anaesthesiology department's specialist in-house on-call rotation (i.e., attending physician).

You may qualify if:

• Anaesthetist specialists performing bronchoskopic tracheal intubation through a supraglottic airway device
• The supraglottic airway device is either i-gelTM or a Ambu® AuraGainTM (4 in total, 2 of each i random order).

You may not qualify if:

• Refuse to participate
• Any other involvement in the research project

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjaellands hospital Hilleroed

Hillerød, 3400, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 8, 2021
• Study Start: January 18, 2021
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: October 4, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)