Airway MorbidityNCT04743440
Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance
An observational study of Airway Morbidity, run by Nordsjaellands Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Bronchoscopic endotracheal intubation through a supraglottic airway device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jan 2021to 20 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- Refuse to participate
- Any other involvement in the research project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchoscopic Endotracheal Intubation Through a Supraglottic Airway Device - an Evaluation of Physician Performance
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.
Read the 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.
- Conditions
- Airway Morbidity
- Being tested
- Bronchoscopic endotracheal intubation through a supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic endotracheal intubation through a supraglottic airway deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | 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. Receives: Device: Bronchoscopic endotracheal intubation through a supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician performance
Overall median physician performance score using an Objective Structured Assessment of Technical Skills (OSATS)-inspired validated global rating scale (GRS)
Measured: 6 months
Secondary outcomes (5)
Checklist score
Median checklist scores using a novel check list developed for the procedure
Measured: 6 months
Pass rate
Overall pass rate (every item in the GRS evaluation has been scored to 3 or more)
Measured: 6 months
Self-reported confidence
Median self-reported confidence score for the procedure during the trial (numeric rating scale (NRS) score 0-10)
Measured: 6 months
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.
Measured: 6 months
interrater-agreement for GRS evaluation
interrater-agreement between assessors for the GRS evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 Jan 2021
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743440
- Sponsor's protocol ID
- bronchoscope-sad-performance
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Endotracheal Intubation Through a Supraglottic Airway Device - an Evaluation of Physician Performance
- ClinicalTrials.gov ID
- NCT04743440
- Acronym / sponsor ID
- bronchoscope-sad-performance
- Conditions
- Airway Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Device: Bronchoscopic endotracheal intubation through a supraglottic airway deviceWe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Refuse to participate
- Any other involvement in the research project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic endotracheal intubation through a supraglottic airway devicePrior 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. | Device | Physicians |
Primary outcome
Physician performance
Time frame: 6 months
Overall median physician performance score using an Objective Structured Assessment of Technical Skills (OSATS)-inspired validated global rating scale (GRS)
5 secondary outcomes
Checklist score
Time frame: 6 months
Pass rate
Time frame: 6 months
Self-reported confidence
Time frame: 6 months
GRS score progression
Time frame: 6 months
interrater-agreement for GRS evaluation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Morbidity, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.