Skip to content

Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04743440
Enrollment
100
Registered
2021-02-08
Start date
2021-01-18
Completion date
2022-08-20
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity

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.

Interventions

DEVICEBronchoscopic 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.

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physician performance6 monthsOverall median physician performance score using an Objective Structured Assessment of Technical Skills (OSATS)-inspired validated global rating scale (GRS)

Secondary

MeasureTime frameDescription
Pass rate6 monthsOverall pass rate (every item in the GRS evaluation has been scored to 3 or more)
Self-reported confidence6 monthsMedian self-reported confidence score for the procedure during the trial (numeric rating scale (NRS) score 0-10)
GRS score progression6 monthsDifference 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 evaluation6 monthsinterrater-agreement between assessors for the GRS evaluation
Checklist score6 monthsMedian checklist scores using a novel check list developed for the procedure

Other

MeasureTime frameDescription
Predictors for time to intubation6 monthsWe will investigate the influence of the following potential predictor variables: Physician characteristics: 1. Self reported experience prior to trial commencement (years since anaesthesiology specialist certification) 2. Self-reported number of key difficult airway procedures/year in patients prior to trial commencement. 3. Self-reported confidence for conducting the procedure, prior to trial commencement (NRS score 0-10), 4. Number of patient participant (1-4), 5. Type of SAD (Ambu® AuraGainTM SAD or i-gelTM SAD); Patient characteristics: 6. sex, 7. age, 8. SARI-score
Predictors for GRS scores6 monthsWe will investigate the influence of the following potential predictor variables: Physician characteristics: 1. Self reported experience prior to trial commencement (years since anaesthesiology specialist certification) 2. Self-reported number of key difficult airway procedures/year in patients prior to trial commencement. 3. Self-reported confidence for conducting the procedure, prior to trial commencement (NRS score 0-10), 4. Number of patient participant (1-4), 5. Type of SAD (Ambu® AuraGainTM SAD or i-gelTM SAD); Patient characteristics: 6. sex, 7. age, 8. SARI-score
Time to intubation6 monthsTime to intubation

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026