Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance

Airway Morbidity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Airway Morbidity

• NCT number: NCT04743440
• Study type: Observational
• Source: Nordsjaellands Hospital
• Status: Completed
• Start date: January 18, 2021
• Completion date: August 20, 2022