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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743440
• Other study ID #: bronchoscope-sad-performance
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: January 2021
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

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.

Locations

Country	Name	City	State
Denmark	Nordsjaellands hospital Hilleroed	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to intubation	Time to intubation	6 months
Other	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
Other	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
Primary	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	Checklist score	Median checklist scores using a novel check list developed for the procedure	6 months
Secondary	Pass rate	Overall pass rate (every item in the GRS evaluation has been scored to 3 or more)	6 months
Secondary	Self-reported confidence	Median self-reported confidence score for the procedure during the trial (numeric rating scale (NRS) score 0-10)	6 months
Secondary	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
Secondary	interrater-agreement for GRS evaluation	interrater-agreement between assessors for the GRS evaluation	6 months