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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Singapore1 site
  • National University Health System

    Singapore, 119074

Other trials in Singapore

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.

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 groups in NCT04477044
Study groupRoleWhat they receive
No GoProNo interventionNo GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin.
GoProExperimentalGoPro 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.

  1. 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

  2. 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)
  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.

  1. First posted20 Jul 2020
  2. Study start12 Jul 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Oct 2019

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
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)
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 12502974
  • Konrad 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 9495429
  • Ti 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

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.

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