Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance

Bronchoscopic Endotracheal Intubation Through a Supraglottic Airway Device - an Evaluation of Physician Performance

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.

Study Overview

• Status: Completed
• Conditions: Airway Morbidity
• Intervention / Treatment: Device: Bronchoscopic endotracheal intubation through a supraglottic airway device

Detailed Description

This study is a preplanned prospective observational substudy of a randomised controlled trial (RCT) with the primary aim to compare time to intubation when using two different supraglottic airway devices (SAD) as conduit for bronchoscopic intubation: the Ambu® AuraGain LMA as compared to the i-gel LMA (reference: I-gel vs AuraGain for Bronchoscopic Intubation Through SGA (ClinicalTrials.gov Identifier: NCT04680169)).

We will include all physicians who provide the airway management in the RCT.

The primary objective is to assess technical competence/performance 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 in multivariate analyses

Airway management will be video recorded. Two anaesthesiologists specialists (assessors), not otherwise involved in the trial and not employed at the hospital, will watch the video recordings of each case of airway management, i.e., the complete airway management provided by a responsible physician participant for each of the included patient participants.

For each case of airway management, they will access the physician's technical performance during the attempt to perform bronchoscopic endotracheal intubation through a SAD.

Assessors will complete a checklist during the procedure. Each item is dichotomously evaluated: done correctly (score=1)/done incorrectly or not performed (score=0). The checklist score represents the sum score for the 30 items (potential sum score range 0-30).

Assessors will evaluate the physician's technical performance using a validated GRS, scored from 8 to 40, for each case of airway management. The GRS is based on 8 items. Each item is scored from one (poor) to five (superior). A score of three is considered 'competent' for each item. The GRS score represent the sum score for all items.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjaellands hospital Hilleroed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Checklist score	Median checklist scores using a novel check list developed for the procedure	6 months
Pass rate	Overall pass rate (every item in the GRS evaluation has been scored to 3 or more)	6 months
Self-reported confidence	Median self-reported confidence score for the procedure during the trial (numeric rating scale (NRS) score 0-10)	6 months
GRS score progression	Difference in GRS scores between the first and the last patient participant (expectedly the fourth patient) in whom the physician conduct airway management.	6 months
interrater-agreement for GRS evaluation	interrater-agreement between assessors for the GRS evaluation	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation	Time to intubation	6 months
Predictors for GRS scores	We will investigate the influence of the following potential predictor variables: Physician characteristics: Self reported experience prior to trial commencement (years since anaesthesiology specialist certification); Self-reported number of key difficult airway procedures/year in patients prior to trial commencement.; Self-reported confidence for conducting the procedure, prior to trial commencement (NRS score 0-10),; Number of patient participant (1-4),; Type of SAD (Ambu® AuraGainTM SAD or i-gelTM SAD);Patient characteristics:; sex,; age,; SARI-score	6 months
Predictors for time to intubation	We will investigate the influence of the following potential predictor variables: Physician characteristics: Self reported experience prior to trial commencement (years since anaesthesiology specialist certification); Self-reported number of key difficult airway procedures/year in patients prior to trial commencement.; Self-reported confidence for conducting the procedure, prior to trial commencement (NRS score 0-10),; Number of patient participant (1-4),; Type of SAD (Ambu® AuraGainTM SAD or i-gelTM SAD);Patient characteristics:; sex,; age,; SARI-score	6 months

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2021
• Primary Completion (ACTUAL): August 20, 2022
• Study Completion (ACTUAL): August 20, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (ACTUAL): February 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: bronchoscope-sad-performance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO