Fiber-optic IntubationNCT04027582
Comparing Simulators Used in Fiber-optic Intubation Training Among Anesthesia Residents
A study testing didactic teaching and simulator practice in people with Fiber-optic Intubation, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Thirty residents in Anesthesia, year one and year two ,and Emergency Medicine Residents, and Family Practice Anesthetists and Emergency residents will undergo teaching in fiber-optic intubation. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Fiber-optic Intubation
- What is being tested?
- didactic teaching and simulator practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jul 2019to Dec 2019
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants:
- Anesthesia first and second year residents in the Competency-based Medical Education Anesthesia Residency program
- They must have less than five prior experiences in fiber-optic intubation.
- Patient inclusion criteria:
- American Society of Anaesthesiologists classification one and two
- Normal airway anatomy.
Who cannot join
- Patient exclusion criteria:
- Emergency surgery
- Risk of aspiration
- History of Malignant Hyperthermia
- History of succinylcholine Apnea.
- American Society of Anaesthesiologists grade greater than two
Show all 9Show fewer
- Abnormal airway anatomy
- Morbid obesity
- Difficult bag mask ventilation.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Kong Eric You-Ten, MD PhD FRCPC, 1-416-586-4800 ext. 5270, eric.you-ten@sinaihealthsystem.ca
Martina Melvin, MB BCh NUI
About this study
Official title: Role of Simulators to Assess Simulator-Based Entrusted Professional Activity in Fiber-optic Intubation and Transfer-ability to Clinical Assessment of Anesthesia Trainees in the Competency By Design Residency Program
Thirty residents in Anesthesia, year one and year two ,and Emergency Medicine Residents, and Family Practice Anesthetists and Emergency residents will undergo teaching in fiber-optic intubation. One half of the group will be randomized to a low fidelity simulator which consists of a wooden block with a series of holes, and the other to a high fidelity simulator, called the ORSIM , which provides a computerised model of the airway. They will practice the procedural skill of fiber-optic intubation on their assigned simulators. Cumulative sum method (CUSUM) learning curves and procedural Entrusted Professional Activities will be obtained for each resident on their assigned simulator. Following this , all residents will undergo a procedural entrusted professional activity with regard to fiber-optic intubation on a low risk , consented patient. The results of the learning curves, Simulator entrusted professional activity and Patient entrusted professional activity will be compared to assess if there is a difference between the low fidelity and high fidelity simulator groups.
Read the detailed description
Fiber-optic intubation(FOI) involves using a thin flexible scope to navigate a breathing tube into a patient's trachea. It is an important skill, as it is required in situations where the breathing tube cannot be inserted using traditional methods. It is a lifesaving skill in terms of securing the 'the difficult airway', in emergency and elective situations. The National Audit Project 4 (NAP4, the largest study on major airway complications in the operating room, emergency department and intensive care unit) have identified the omission of FOI when indicated as a major contributor to airway morbidity and mortality . Recommendations from NAP4 included ensuring anesthesiologists are trained in the use of FOI.
Medical training in Canada and globally is undergoing a major transformation to competency-based medical education (CBME). Within the next decade, all residency programs in Canada will be following a competency-based curriculum, as mandated by the Royal College of Physicians and Surgeons of Canada (Royal College) and the College of Family Physicians of Canada. CBME emphasizes the demonstration of competence in skills and abilities deemed essential for future practice and de-emphasizes time and duration .
While competence is assessed by several metrics in CBME, the entrustable professional activities (EPAs)framework is one approach to assessment. EPAs are specific tasks in the clinical environment that a supervisor will delegate to a resident once sufficient competence has been demonstrated .
Competency-based medical education(CBME) requires residents to demonstrate competency in key skills; simulators have an important role in facilitating this learning in a safe environment without harming patients. Currently, little is known on the role of simulators on acquiring competence of Fiber-optic intubation and assessment of simulator-based Entrusted Professional Activity (EPA) and transfer-ability to patient -based EPA.
The focus of the study is the learning aspect with regards to fiber-optic intubation.
The hypothesis is that simulator-based EPA is transferable to clinical-based EPA and that clinical performance is better after training with a high -fidelity simulator.
Methods:
This is a 2-arm comparison study to be conducted at Mount Sinai Hospital, Toronto.
After written informed consent, resident participants will be randomized to the low fidelity simulator (LFS n=15) and the high- fidelity simulator (ORSIM, n=15). Participants consist of anesthesia 1st - 2nd year residents in the Competency-based Medical Education Anesthesia Residency program, Emergency Medicine Residents, Family Practice Anesthetists and Emergency Medicine Residents, with less than five prior experiences in fiberoptic intubations.
The resident will undergo a teaching intervention consisting of a didactic Power-point presentation and video on FOI, {https://www.youtube.com/watch?v=wDLrRHS7Urw}, followed with hands-on practice on the LFS or ORSIM. The didactic teaching will be group based, but the hands-on simulator practice will be one to one.
Generating Learning Curve (CUSUM) for Competence:
After the teaching session, the resident participant will generate a learning curve for a series of fiberoptic intubations on the respective simulator using the cumulative sum method (CUSUM).The resident will be allowed 20 attempts. Residents will be considered simulator-competent if they reach 90% success rate.
Simulator-based Entrusted Professional Activity (EPA) Assessment:
Within one week later the resident will be assessed to complete an EPA on fiber-optic intubation using their assigned simulator. Each performance will be video-recorded for data analysis by the research assistant.
Transfer to Clinical-based EPA Assessment:
Thereafter and within two weeks, the resident will then perform a fiber-optic intubation on an anesthetized patient in the Operating Room. The fiberoptic intubation on a patient will be limited to a maximum of 8 minutes since this is the apnea time where desaturation (hypoxia) will occur in a patient induced with general anesthesia and muscle paralysis who underwent adequate pre-oxygenation. .
Written informed consent will be obtained from each patient.
The performance of the Simulator based EPA and clinical EPA will be video-recorded. No patient or resident identifiers will be recorded, the patient's eyes will be covered with a surgical green towel, leaving the mouth and nose exposed to bag mas ventilate, the camera will focus on the resident's hands.
Two experienced observers will grade the intubations using a validated checklist and global rating scale. They will be blinded to the group allocation.
An experienced anesthetist not involved in the study will be present in the operating room to assist the resident and take over the intubation if they deem necessary for patient safety.
The total time commitment for the resident will be a maximum of 2 hours.
- Conditions
- Fiber-optic Intubation
- Being tested
- didactic teaching and simulator practice
- Keywords
- ORSIM, Entrustable Professional Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
didactic teaching and simulator practiceOther
the trainee will undergo didactic teaching on fiber-optic intubation followed by hands on practice on their assigned simulator
| Study group | Role | What they receive |
|---|---|---|
| Low Fidelity Simulator - Wooden block | Active comparator | This simulator consists of a simple series of wooden panels with holes. The resident learns how to manipulate the fiberoptic bronchoscope through the holes. Receives: Other: didactic teaching and simulator practice |
| High fidelity Simulator - ORSIM | Active comparator | The ORSIM® bronchoscopy is a virtual reality simulator (Airway Simulation Limited, Auckland, New Zealand). It consists of hardware and software components that interact to create a high-fidelity virtual reality simulation. A replica fiberoptic scope is advanced by the resident through a desktop sensor, which is connected to a laptop computer. The laptop software program provides a virtual airway in which the user must navigate the probe. Receives: Other: didactic teaching and simulator practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative sum learning curve
Primary outcome: Cumulative sum learning curves will be generated as the primary outcome measure as the number of fiber-optics done on each respective simulator to achieve competence, defined as 90% success rate in a series of fiber-optic intubations. Each successful attempt on the respective simulator must be completed within eight minutes (ie apnea time)
Measured: eight minutes
Secondary outcomes (1)
Time
Fiber-optic scope entry to mouth to successful pass through vocal cords, 1-2 cm above the carina.
Measured: eight minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start19 Jul 2019
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fiber-optic IntubationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-arm comparison study to be conducted at Mount Sinai Hospital, Toronto. After written informed consent, participants will be randomized to the low fidelity simulator (LFS n=15) and the high- fidelity simulator (ORSIM, n=15). Participants consist of anesthesia 1st - 2nd year residents in the Competency-based Medical Education Anesthesia Residency program, Emergency Medicine Residents, Family Practice Anesthetists and Emergency Residents with less than five prior experiences in fiberoptic intubations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric You-Ten, Mount Sinai Hospital, Canada
- Investigators
- Kong Eric You-Ten, MD PhD FRCPC, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027582
- Sponsor's protocol ID
- 19-0020-A
- Status last verified
- Oct 2019
- First submitted
- 18 Jul 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Simulators to Assess Simulator-Based Entrusted Professional Activity in Fiber-optic Intubation and Transfer-ability to Clinical Assessment of Anesthesia Trainees in the Competency By Design Residency Program
- ClinicalTrials.gov ID
- NCT04027582
- Acronym / sponsor ID
- 19-0020-A
- Conditions
- Fiber-optic Intubation
- Keywords
- ORSIM, Entrustable Professional Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Jul 2019 (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.
Thirty residents in Anesthesia, year one and year two ,and Emergency Medicine Residents, and Family Practice Anesthetists and Emergency residents will undergo teaching in fiber-optic intubation. One half of the group will be randomized to a low fidelity simulator which consists of a wooden block with a series of holes, and the other to a high fidelity simulator, called the ORSIM , which provides a computerised model of the airway. They will practice the procedural skill of fiber-optic intubation on their assigned simulators. Cumulative sum method (CUSUM) learning curves and procedural Entrusted Professional Activities will be obtained for each resident on their assigned simulator. Following this , all residents will undergo a procedural entrusted professional activity with regard to fiber-optic intubation on a low risk , consented patient. The results of the learning curves, Simulator entrusted professional activity and Patient entrusted professional activity will be compared to assess if there is a difference between the low fidelity and high fidelity simulator groups.
Detailed description
Fiber-optic intubation(FOI) involves using a thin flexible scope to navigate a breathing tube into a patient's trachea. It is an important skill, as it is required in situations where the breathing tube cannot be inserted using traditional methods. It is a lifesaving skill in terms of securing the 'the difficult airway', in emergency and elective situations. The National Audit Project 4 (NAP4, the largest study on major airway complications in the operating room, emergency department and intensive care unit) have identified the omission of FOI when indicated as a major contributor to airway morbidity and mortality . Recommendations from NAP4 included ensuring anesthesiologists are trained in the use of FOI.
Medical training in Canada and globally is undergoing a major transformation to competency-based medical education (CBME). Within the next decade, all residency programs in Canada will be following a competency-based curriculum, as mandated by the Royal College of Physicians and Surgeons of Canada (Royal College) and the College of Family Physicians of Canada. CBME emphasizes the demonstration of competence in skills and abilities deemed essential for future practice and de-emphasizes time and duration .
While competence is assessed by several metrics in CBME, the entrustable professional activities (EPAs)framework is one approach to assessment. EPAs are specific tasks in the clinical environment that a supervisor will delegate to a resident once sufficient competence has been demonstrated .
Competency-based medical education(CBME) requires residents to demonstrate competency in key skills; simulators have an important role in facilitating this learning in a safe environment without harming patients. Currently, little is known on the role of simulators on acquiring competence of Fiber-optic intubation and assessment of simulator-based Entrusted Professional Activity (EPA) and transfer-ability to patient -based EPA.
The focus of the study is the learning aspect with regards to fiber-optic intubation.
The hypothesis is that simulator-based EPA is transferable to clinical-based EPA and that clinical performance is better after training with a high -fidelity simulator.
Methods:
This is a 2-arm comparison study to be conducted at Mount Sinai Hospital, Toronto.
After written informed consent, resident participants will be randomized to the low fidelity simulator (LFS n=15) and the high- fidelity simulator (ORSIM, n=15). Participants consist of anesthesia 1st - 2nd year residents in the Competency-based Medical Education Anesthesia Residency program, Emergency Medicine Residents, Family Practice Anesthetists and Emergency Medicine Residents, with less than five prior experiences in fiberoptic intubations.
The resident will undergo a teaching intervention consisting of a didactic Power-point presentation and video on FOI, {https://www.youtube.com/watch?v=wDLrRHS7Urw}, followed with hands-on practice on the LFS or ORSIM. The didactic teaching will be group based, but the hands-on simulator practice will be one to one.
Generating Learning Curve (CUSUM) for Competence:
After the teaching session, the resident participant will generate a learning curve for a series of fiberoptic intubations on the respective simulator using the cumulative sum method (CUSUM).The resident will be allowed 20 attempts. Residents will be considered simulator-competent if they reach 90% success rate.
Simulator-based Entrusted Professional Activity (EPA) Assessment:
Within one week later the resident will be assessed to complete an EPA on fiber-optic intubation using their assigned simulator. Each performance will be video-recorded for data analysis by the research assistant.
Transfer to Clinical-based EPA Assessment:
Thereafter and within two weeks, the resident will then perform a fiber-optic intubation on an anesthetized patient in the Operating Room. The fiberoptic intubation on a patient will be limited to a maximum of 8 minutes since this is the apnea time where desaturation (hypoxia) will occur in a patient induced with general anesthesia and muscle paralysis who underwent adequate pre-oxygenation. .
Written informed consent will be obtained from each patient.
The performance of the Simulator based EPA and clinical EPA will be video-recorded. No patient or resident identifiers will be recorded, the patient's eyes will be covered with a surgical green towel, leaving the mouth and nose exposed to bag mas ventilate, the camera will focus on the resident's hands.
Two experienced observers will grade the intubations using a validated checklist and global rating scale. They will be blinded to the group allocation.
An experienced anesthetist not involved in the study will be present in the operating room to assist the resident and take over the intubation if they deem necessary for patient safety.
The total time commitment for the resident will be a maximum of 2 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 2-arm comparison study to be conducted at Mount Sinai Hospital, Toronto. After written informed consent, participants will be randomized to the low fidelity simulator (LFS n=15) and the high- fidelity simulator (ORSIM, n=15). Participants consist of anesthesia 1st - 2nd year residents in the Competency-based Medical Education Anesthesia Residency program, Emergency Medicine Residents, Family Practice Anesthetists and Emergency Residents with less than five prior experiences in fiberoptic intubations.
| Arm | Type | Receives |
|---|---|---|
| Low Fidelity Simulator - Wooden block | Active comparator | Other: didactic teaching and simulator practiceThis simulator consists of a simple series of wooden panels with holes. The resident learns how to manipulate the fiberoptic bronchoscope through the holes. |
| High fidelity Simulator - ORSIM | Active comparator | Other: didactic teaching and simulator practiceThe ORSIM® bronchoscopy is a virtual reality simulator (Airway Simulation Limited, Auckland, New Zealand). It consists of hardware and software components that interact to create a high-fidelity virtual reality simulation. A replica fiberoptic scope is advanced by the resident through a desktop sensor, which is connected to a laptop computer. The laptop software program provides a virtual airway in which the user must navigate the probe. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Anesthesia first and second year residents in the Competency-based Medical Education Anesthesia Residency program
- They must have less than five prior experiences in fiber-optic intubation.
- American Society of Anaesthesiologists classification one and two
- Normal airway anatomy.
Key exclusion criteria (9 listed)
- Emergency surgery
- Risk of aspiration
- History of Malignant Hyperthermia
- History of succinylcholine Apnea.
- American Society of Anaesthesiologists grade greater than two
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 |
|---|---|---|
| didactic teaching and simulator practicethe trainee will undergo didactic teaching on fiber-optic intubation followed by hands on practice on their assigned simulator | Other | High fidelity Simulator - ORSIM, Low Fidelity Simulator - Wooden block |
Primary outcome
Cumulative sum learning curve
Time frame: eight minutes
Primary outcome: Cumulative sum learning curves will be generated as the primary outcome measure as the number of fiber-optics done on each respective simulator to achieve competence, defined as 90% success rate in a series of fiber-optic intubations. Each successful attempt on the respective simulator must be completed within eight minutes (ie apnea time)
1 secondary outcome
Time
Time frame: eight minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: Yes. All individual patient data that underlie results in a publication
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.
Kong Eric You-Ten, MD PhD FRCPC principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing didactic teaching and simulator practice in people with Fiber-optic Intubation, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kong Eric You-Ten, MD PhD FRCPC (1-416-586-4800 ext. 5270, eric.you-ten@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative sum learning curve (time frame: eight minutes). 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 28 Oct 2019.