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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Kong Eric You-Ten, MD PhD FRCPC contact

1-416-586-4800 ext. 5270

eric.you-ten@sinaihealthsystem.ca

Canada1 site, 1 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

    Recruiting

Other trials in Canada

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.

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 groups in NCT04027582
Study groupRoleWhat they receive
Low Fidelity Simulator - Wooden blockActive comparatorThis 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 - ORSIMActive comparatorThe 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.

  1. 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)
  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.

  1. First posted22 Jul 2019
  2. Study start19 Jul 2019
  3. Primary completionNov 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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)
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

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.

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