Clinical trial NCT04743440: Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance
Official title: Bronchoscopic Endotracheal Intubation Through a Supraglottic Airway Device - an Evaluation of Physician Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Morbidity
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician performance
timeFrame: 6 months
Secondary outcomes:
measure: Checklist score
timeFrame: 6 months
measure: Pass rate
timeFrame: 6 months
measure: Self-reported confidence
timeFrame: 6 months
measure: GRS score progression
timeFrame: 6 months
measure: interrater-agreement for GRS evaluation
timeFrame: 6 months
Other outcomes:
measure: Time to intubation
timeFrame: 6 months
measure: Predictors for GRS scores
timeFrame: 6 months
measure: Predictors for time to intubation
timeFrame: 6 months
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands hospital Hilleroed
Study officials:
References: