Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance

Completed

• Conditions: Airway Morbidity
• Interventions: Device: Bronchoscopic endotracheal intubation through a supraglottic airway device

• Registration Number: NCT04743440
• Lead Sponsor: Nordsjaellands Hospital

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.

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 Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-18
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Primary Completion: 2022-08-20
• Study Completion: 2022-08-20
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physicians	Bronchoscopic endotracheal intubation through a supraglottic airway device	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.

Primary Outcome Measures

Name	Time	Method
Physician performance	6 months	Overall median physician performance score using an Objective Structured Assessment of Technical Skills (OSATS)-inspired validated global rating scale (GRS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nordsjaellands hospital Hilleroed; 🇩🇰 Hillerød, Denmark