Intubation; Difficult or FailedNCT04477044
Use of Point-of-View Camera to Faciliate Learning of Endotracheal Intubation
A study testing Study Group in people with Intubation; Difficult or Failed and Anesthesia, run by National University of Singapore at 1 site in Singapore.
Trial summary
The study team proposes that mounting a point-of-view camera on the student's head will enable the team to view what the student is seeing in real-time when intubating with a normal laryngoscope. This will allow the team to guide the students accurately. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Anesthesia
- What is being tested?
- Study Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Jul 2016to 31 Oct 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All medical students rotating through a 2-week posting in Anaesthesia at NUHS during Year 4 of medical school
Who cannot join
- NIL
Trial locations and contacts
1 site in 1 country.
About this study
The study team proposes that mounting a point-of-view camera on the student's head will enable the team to view what the student is seeing in real-time when intubating with a normal laryngoscope. This will allow the team to guide the students accurately. When used in conjunction with the established simulation programme in the department, it is believed that this will improve the learning and retention of this skill when compared to standard teaching.
Read the detailed description
The ability to correctly perform an endotracheal intubation is a life-saving skill that every doctor should possess. It is an integral part of established protocols for resuscitation and advanced cardiac life support (ACLS). It is an essential procedural skill that is taught to all students at the Yong Loo Lin School of Medicine, NUS. It is also recommended by the American Association of Medical Colleges as an essential procedural skill for medical students to learn.
Timely and correctly performed endotracheal intubation can be life-saving because it maintains and protects the airway, reliably provides adequate tidal volumes, frees the hands of rescuers, allows the removal of airway secretions and provides a route for giving drugs. However, poorly performed endotracheal intubation exposes patients to the life-threatening risks associated with the unrecognised misplacement of a tracheal tube and leads to delays in resuscitative efforts.
Unfortunately, there is a comparatively high failure rate associated with endotracheal intubation because this skill is difficult to learn and retain. Mulcaster et al reported that, to achieve a 90% intubation success rate, a mean of 47 intubation attempts were required. In a similar study, Konrad et al found that a mean of 57 attempts were required to achieve a 90% intubation success rate. This difficulty in learning is compounded by the finding that, without repeated practice, the ability to perform endotracheal intubation successfully diminishes rapidly. The intubation success rate of infrequent users who have successfully learned to intubate has been shown to fall to as little as 57% after only 6 months. Clearly, there is a need to improve the learning and retention of endotracheal intubation.
The PI previously published a randomized controlled trial in the journal Medical Education to study the utility of experiential learning on a simulator in the learning and retention of this skill. It was showed that with experiential learning, more students were able to intubate a manikin at 3 months (64.5% vs. 36.9%, p<0.001). With repeated learning (refresher every 3 months), 86% of students were able to successfully perform endotracheal intubation at 12 months.
However, there are limitations to acquiring this skill on a simulator, as it has been argued that expertise gained on manikins may not translate into successful intubations in patients. Learning on actual patients is desirable, but impractical given the large number of students in our medical school. On average, each YLLSoM student only intubates between 3-5 patients, far less than the 47-57 endotracheal intubations necessary to gain expertise as cited earlier. Combining the learning experiences on the simulator with that on actual patients appears to be the best solution.
Therefore it is important to optimize the limited learning opportunities on patients. However, this is often difficult because the mouth is small, and the view of the pharyngeal structures is limited. The tutor will not be able to view what the student is seeing as there is only one line of vision. More recently, video-laryngoscopes, which are laryngoscopes with a camera at its tip, have emerged as an effective means of teaching endotracheal intubation. However, the technique of using the video-laryngoscope differs from using the common laryngoscope due to its different shape and the requirement that the student looks at the screen rather than into the patient's mouth. Hence it is unclear if the ability to successfully perform endotracheal intubation with a video-laryngoscope necessarily translates into the ability to perform endotracheal intubation with a normal laryngoscope.
The study team proposes that mounting a point-of-view camera on the student's head will enable the team to view what the student is seeing in real-time when intubating with a normal laryngoscope. This will allow the team to guide the students accurately. When used in conjunction with the established simulation programme in the department, it is believed that this will improve the learning and retention of this skill when compared to standard teaching.
Methods:
Students will be randomised into 2 groups. For the study group, students will have a GoPro Hero4 camera mounted on their head which will be linked via Wi-Fi to allow real-time streaming of the view onto a laptop, while students in control group will have a regular type of tutorial and practicing session. Data such as time to successful intubation and Cormack Lehane laryngoscopy view will be recorded. At the end of the session, tutors will use a debrief guide to give feedback to students. Students from the study group will be given a questionnaire to be completed at the end of the session.
These students will be recalled 3 months later. Each student will individually be assessed on his or her intubation skill using 2 different manikin: a normal airway manikin and a difficult airway manikin. All the students will be wearing the GoPro Hero4 this time round. Data such as time to successful intubation and Cormack Lehane laryngoscopy view will be recorded. Students will be given feedback as appropriate by tutors for their learning purposes using the same debrief guide. There will be questionnaires for both students and tutors to fill in this time.
- Conditions
- Intubation; Difficult or Failed, Anesthesia
- Being tested
- Study Group
- Keywords
- Medical Education, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study GroupOther
Also called GoPro
GoPro Hero4 to be mounted on the participant's forehead while performing intubation on a manikin.
| Study group | Role | What they receive |
|---|---|---|
| No GoPro | No intervention | No GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin. |
| GoPro | Experimental | GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin. Receives: Other: Study Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Timing between GoPro and non-GoPro group at first intubation session
To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group
Measured: During procedure of first intubation session
Intubation Timing between GoPro and non-GoPro group at 3 months follow-up session
To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group
Measured: During procedure of 3-month follow-up session
Secondary outcomes (1)
Usefulness of GoPro in learning
To find out the usefulness of GoPro in learning using a questionnaire comprising of yes/no questions
Measured: Immediately after first intubation tryout session and follow-up session 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start12 Jul 2016
- Primary completion31 Dec 2018
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomised to 2 groups, either in the study group having a GoPro Hero4 camera mounted on their head or control group with no GoPro Hero4 camera mounted on their head
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUS Anaesthesia, National University of Singapore
- Investigators
- Lian Kah Ti, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477044
- Sponsor's protocol ID
- NUS IRB B-15-274
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulcaster JT, Mills J, Hung OR, MacQuarrie K, Law JA, Pytka S, Imrie D, Field C. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003 Jan;98(1):23-7. doi: 10.1097/00000542-200301000-00007.
PubMed 12502974Konrad C, Schupfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesth Analg. 1998 Mar;86(3):635-9. doi: 10.1097/00000539-199803000-00037.
PubMed 9495429Ti LK, Chen FG, Tan GM, Tan WT, Tan JM, Shen L, Goy RW. Experiential learning improves the learning and retention of endotracheal intubation. Med Educ. 2009 Jul;43(7):654-60. doi: 10.1111/j.1365-2923.2009.03399.x.
PubMed 19573188
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Point-of-View Camera to Faciliate Learning of Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT04477044
- Acronym / sponsor ID
- NUS IRB B-15-274
- Conditions
- Intubation; Difficult or Failed, Anesthesia
- Keywords
- Medical Education, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 20 Jul 2020 (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.
The study team proposes that mounting a point-of-view camera on the student's head will enable the team to view what the student is seeing in real-time when intubating with a normal laryngoscope. This will allow the team to guide the students accurately. When used in conjunction with the established simulation programme in the department, it is believed that this will improve the learning and retention of this skill when compared to standard teaching.
Detailed description
The ability to correctly perform an endotracheal intubation is a life-saving skill that every doctor should possess. It is an integral part of established protocols for resuscitation and advanced cardiac life support (ACLS). It is an essential procedural skill that is taught to all students at the Yong Loo Lin School of Medicine, NUS. It is also recommended by the American Association of Medical Colleges as an essential procedural skill for medical students to learn.
Timely and correctly performed endotracheal intubation can be life-saving because it maintains and protects the airway, reliably provides adequate tidal volumes, frees the hands of rescuers, allows the removal of airway secretions and provides a route for giving drugs. However, poorly performed endotracheal intubation exposes patients to the life-threatening risks associated with the unrecognised misplacement of a tracheal tube and leads to delays in resuscitative efforts.
Unfortunately, there is a comparatively high failure rate associated with endotracheal intubation because this skill is difficult to learn and retain. Mulcaster et al reported that, to achieve a 90% intubation success rate, a mean of 47 intubation attempts were required. In a similar study, Konrad et al found that a mean of 57 attempts were required to achieve a 90% intubation success rate. This difficulty in learning is compounded by the finding that, without repeated practice, the ability to perform endotracheal intubation successfully diminishes rapidly. The intubation success rate of infrequent users who have successfully learned to intubate has been shown to fall to as little as 57% after only 6 months. Clearly, there is a need to improve the learning and retention of endotracheal intubation.
The PI previously published a randomized controlled trial in the journal Medical Education to study the utility of experiential learning on a simulator in the learning and retention of this skill. It was showed that with experiential learning, more students were able to intubate a manikin at 3 months (64.5% vs. 36.9%, p<0.001). With repeated learning (refresher every 3 months), 86% of students were able to successfully perform endotracheal intubation at 12 months.
However, there are limitations to acquiring this skill on a simulator, as it has been argued that expertise gained on manikins may not translate into successful intubations in patients. Learning on actual patients is desirable, but impractical given the large number of students in our medical school. On average, each YLLSoM student only intubates between 3-5 patients, far less than the 47-57 endotracheal intubations necessary to gain expertise as cited earlier. Combining the learning experiences on the simulator with that on actual patients appears to be the best solution.
Therefore it is important to optimize the limited learning opportunities on patients. However, this is often difficult because the mouth is small, and the view of the pharyngeal structures is limited. The tutor will not be able to view what the student is seeing as there is only one line of vision. More recently, video-laryngoscopes, which are laryngoscopes with a camera at its tip, have emerged as an effective means of teaching endotracheal intubation. However, the technique of using the video-laryngoscope differs from using the common laryngoscope due to its different shape and the requirement that the student looks at the screen rather than into the patient's mouth. Hence it is unclear if the ability to successfully perform endotracheal intubation with a video-laryngoscope necessarily translates into the ability to perform endotracheal intubation with a normal laryngoscope.
The study team proposes that mounting a point-of-view camera on the student's head will enable the team to view what the student is seeing in real-time when intubating with a normal laryngoscope. This will allow the team to guide the students accurately. When used in conjunction with the established simulation programme in the department, it is believed that this will improve the learning and retention of this skill when compared to standard teaching.
Methods:
Students will be randomised into 2 groups. For the study group, students will have a GoPro Hero4 camera mounted on their head which will be linked via Wi-Fi to allow real-time streaming of the view onto a laptop, while students in control group will have a regular type of tutorial and practicing session. Data such as time to successful intubation and Cormack Lehane laryngoscopy view will be recorded. At the end of the session, tutors will use a debrief guide to give feedback to students. Students from the study group will be given a questionnaire to be completed at the end of the session.
These students will be recalled 3 months later. Each student will individually be assessed on his or her intubation skill using 2 different manikin: a normal airway manikin and a difficult airway manikin. All the students will be wearing the GoPro Hero4 this time round. Data such as time to successful intubation and Cormack Lehane laryngoscopy view will be recorded. Students will be given feedback as appropriate by tutors for their learning purposes using the same debrief guide. There will be questionnaires for both students and tutors to fill in this time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be randomised to 2 groups, either in the study group having a GoPro Hero4 camera mounted on their head or control group with no GoPro Hero4 camera mounted on their head
| Arm | Type | Receives |
|---|---|---|
| No GoPro | No intervention | –No GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin. |
| GoPro | Experimental | Other: Study GroupGoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All medical students rotating through a 2-week posting in Anaesthesia at NUHS during Year 4 of medical school
Key exclusion criteria (1 listed)
- NIL
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 |
|---|---|---|
| Study GroupAlso: GoProGoPro Hero4 to be mounted on the participant's forehead while performing intubation on a manikin. | Other | GoPro |
Primary outcome
Intubation Timing between GoPro and non-GoPro group at first intubation session
Time frame: During procedure of first intubation session
To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group
Intubation Timing between GoPro and non-GoPro group at 3 months follow-up session
Time frame: During procedure of 3-month follow-up session
To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group
1 secondary outcome
Usefulness of GoPro in learning
Time frame: Immediately after first intubation tryout session and follow-up session 3 months later
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 20 Jul 2020.
- Background: PubMed 12502974Mulcaster JT, Mills J, Hung OR, MacQuarrie K, Law JA, Pytka S, Imrie D, Field C. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003 Jan;98(1):23-7. doi: 10.1097/00000542-200301000-00007.
- Background: PubMed 9495429Konrad C, Schupfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesth Analg. 1998 Mar;86(3):635-9. doi: 10.1097/00000539-199803000-00037.
- Background: PubMed 19573188Ti LK, Chen FG, Tan GM, Tan WT, Tan JM, Shen L, Goy RW. Experiential learning improves the learning and retention of endotracheal intubation. Med Educ. 2009 Jul;43(7):654-60. doi: 10.1111/j.1365-2923.2009.03399.x.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
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.
Lian Kah Ti principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group in people with Intubation; Difficult or Failed and Anesthesia, run by National University of Singapore at 1 site in Singapore.
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 1 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 20 Jul 2020. 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 Singapore. 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?
Intubation Timing between GoPro and non-GoPro group at first intubation session (time frame: During procedure of first intubation session). The study lists 2 primary outcomes in all. 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 NCT04477044, which also lists 3 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 20 Jul 2020.