Airway ManagementNCT02263300
Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
An observational study of Airway Management, run by Northwestern University at 1 site in United States.
Trial summary
Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on the development of fiberoptic intubation skills? Is it necessary to teach both orientations or is the supine view transferable to the upright position? Which method demonstrates longer skill retention? The hypotheses: Both… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 30 Mar 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Third and fourth year medical students.
Who may be able to join
- Third and fourth year medical student
- no previous training in fiberoptic intubation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Spatial Orientation Affect the Rate of Learning Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on the development of fiberoptic intubation skills?
Is it necessary to teach both orientations or is the supine view transferable to the upright position?
Which method demonstrates longer skill retention?
The hypotheses: Both orientations must be practiced and the upright skill is harder to learn but is retained for longer.
Read the detailed description
Following IRB approval, written consent to participate in the study will be obtained from medical students
Phase one :
Forty medical students, novices in fiberoptic intubation use will be recruited and randomly assigned into one of two groups:
Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions.
Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINEposition.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions.
Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
teaching testing testing week testing testing
Group A supine supine upright random random random random B upright upright supine random random random random C supine upright supine random random random random D upright supine upright random random
Phase two:
Study candidates will randomly be assigned(20 per group) to practice for 15minutes/day their intubations skills with the iLarynx application downloaded to their smart phones or iPads. The other group (20candidates) will be asked not to practice their intubation skills. At the end of one week both groups will be retested on a mannequin by the same blinded examiner to obtain a new learning curve, global assessment score and checklist. Both orientations of the mannequin will be tested and the order randomly assigned.
- Conditions
- Airway Management
- Keywords
- Fiberoptic Intubation, Medical student, Virtual larynx, Didactic Training, Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Supine- Supine | Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions. | |
| Upright-upright | Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions. | |
| Supine -upright | Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions. | |
| Upright - supine | Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elapsed time to mannequin intubation with fiberoptic scope.
The elapsed time of intubation with fiberoptic scope of a mannequin. Stop watch is started at passing teeth and ends when scope reaches carina.
Measured: 2 minutes
Secondary outcomes (2)
Global rating scale (GRS)
Global rating scale (GRS) and assessment of medical students skill demonstrated during fiberoptic intubation of a mannequin on a score of 1-5 1 being very poor and 5 being clearly superior.
Measured: 2 minutes
Examiner check list (ECL) scores
The ECL will be used to measure the students proficiency with the fiberoptic scope on a scale of 0-5 for each attempt.
Measured: 2 mintues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion30 Mar 2015
- Study completion30 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Glassenberg, Northwestern University
- Investigators
- Raymond Glassenberg, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263300
- Sponsor's protocol ID
- STU00098465
- Status last verified
- May 2023
- First submitted
- 24 Sep 2014
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Badurdeen S, Abdul-Samad O, Story G, Wilson C, Down S, Harris A. Nintendo Wii video-gaming ability predicts laparoscopic skill. Surg Endosc. 2010 Aug;24(8):1824-8. doi: 10.1007/s00464-009-0862-z. Epub 2010 Jan 28.
PubMed 20108147Boet S, Bould MD, Schaeffer R, Fischhof S, Stojeba N, Naik VN, Diemunsch P. Learning fibreoptic intubation with a virtual computer program transfers to 'hands on' improvement. Eur J Anaesthesiol. 2010 Jan;27(1):31-5. doi: 10.1097/EJA.0b013e3283312725.
PubMed 19851113De Oliveira GS Jr, Glassenberg R, Chang R, Fitzgerald P, McCarthy RJ. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013 Oct;68(10):1053-8. doi: 10.1111/anae.12379. Epub 2013 Aug 19.
PubMed 23952805Goldmann K, Steinfeldt T. Acquisition of basic fiberoptic intubation skills with a virtual reality airway simulator. J Clin Anesth. 2006 May;18(3):173-8. doi: 10.1016/j.jclinane.2005.08.021.
PubMed 16731318Chandra DB, Savoldelli GL, Joo HS, Weiss ID, Naik VN. Fiberoptic oral intubation: the effect of model fidelity on training for transfer to patient care. Anesthesiology. 2008 Dec;109(6):1007-13. doi: 10.1097/ALN.0b013e31818d6c3c.
PubMed 19034097Marsland CP, Robinson BJ, Chitty CH, Guy BJ. Acquisition and maintenance of endoscopic skills: developing an endoscopic dexterity training system for anesthesiologists. J Clin Anesth. 2002 Dec;14(8):615-9. doi: 10.1016/s0952-8180(02)00456-7.
PubMed 12565124
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Spatial Orientation Affect the Rate of Learning Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02263300
- Acronym / sponsor ID
- STU00098465
- Conditions
- Airway Management
- Keywords
- Fiberoptic Intubation, Medical student, Virtual larynx, Didactic Training, Medical Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 30 Mar 2015 (actual)
- Study completion
- 30 Mar 2015 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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.
Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on the development of fiberoptic intubation skills?
Is it necessary to teach both orientations or is the supine view transferable to the upright position?
Which method demonstrates longer skill retention?
The hypotheses: Both orientations must be practiced and the upright skill is harder to learn but is retained for longer.
Detailed description
Following IRB approval, written consent to participate in the study will be obtained from medical students
Phase one :
Forty medical students, novices in fiberoptic intubation use will be recruited and randomly assigned into one of two groups:
Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions.
Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINEposition.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions.
Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
teaching testing testing week testing testing
Group A supine supine upright random random random random B upright upright supine random random random random C supine upright supine random random random random D upright supine upright random random
Phase two:
Study candidates will randomly be assigned(20 per group) to practice for 15minutes/day their intubations skills with the iLarynx application downloaded to their smart phones or iPads. The other group (20candidates) will be asked not to practice their intubation skills. At the end of one week both groups will be retested on a mannequin by the same blinded examiner to obtain a new learning curve, global assessment score and checklist. Both orientations of the mannequin will be tested and the order randomly assigned.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supine- Supine | – | –Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions. |
| Upright-upright | – | –Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions. |
| Supine -upright | – | –Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions. |
| Upright - supine | – | –Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Third and fourth year medical students.
Key inclusion criteria (2 listed)
- Third and fourth year medical student
- no previous training in fiberoptic intubation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elapsed time to mannequin intubation with fiberoptic scope.
Time frame: 2 minutes
The elapsed time of intubation with fiberoptic scope of a mannequin. Stop watch is started at passing teeth and ends when scope reaches carina.
2 secondary outcomes
Global rating scale (GRS)
Time frame: 2 minutes
Examiner check list (ECL) scores
Time frame: 2 mintues
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 17 May 2023.
- Background: PubMed 20108147Badurdeen S, Abdul-Samad O, Story G, Wilson C, Down S, Harris A. Nintendo Wii video-gaming ability predicts laparoscopic skill. Surg Endosc. 2010 Aug;24(8):1824-8. doi: 10.1007/s00464-009-0862-z. Epub 2010 Jan 28.
- Background: PubMed 19851113Boet S, Bould MD, Schaeffer R, Fischhof S, Stojeba N, Naik VN, Diemunsch P. Learning fibreoptic intubation with a virtual computer program transfers to 'hands on' improvement. Eur J Anaesthesiol. 2010 Jan;27(1):31-5. doi: 10.1097/EJA.0b013e3283312725.
- Background: PubMed 23952805De Oliveira GS Jr, Glassenberg R, Chang R, Fitzgerald P, McCarthy RJ. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013 Oct;68(10):1053-8. doi: 10.1111/anae.12379. Epub 2013 Aug 19.
- Background: PubMed 16731318Goldmann K, Steinfeldt T. Acquisition of basic fiberoptic intubation skills with a virtual reality airway simulator. J Clin Anesth. 2006 May;18(3):173-8. doi: 10.1016/j.jclinane.2005.08.021.
- Background: PubMed 19034097Chandra DB, Savoldelli GL, Joo HS, Weiss ID, Naik VN. Fiberoptic oral intubation: the effect of model fidelity on training for transfer to patient care. Anesthesiology. 2008 Dec;109(6):1007-13. doi: 10.1097/ALN.0b013e31818d6c3c.
- Background: PubMed 12565124Marsland CP, Robinson BJ, Chitty CH, Guy BJ. Acquisition and maintenance of endoscopic skills: developing an endoscopic dexterity training system for anesthesiologists. J Clin Anesth. 2002 Dec;14(8):615-9. doi: 10.1016/s0952-8180(02)00456-7.
- 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.
Raymond Glassenberg, MD principal investigator
Northwestern University
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 Management, run by Northwestern University at 1 site in United States.
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 1 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 17 May 2023. 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 United States. 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?
Elapsed time to mannequin intubation with fiberoptic scope. (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263300, which also lists 6 linked publications.
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 17 May 2023.