Critical IncidentNCT07861555
Feasibility Study of an Interactive Remote Supervising Platform for Critical Care: A Randomized Study
A study testing Hololens2(Microsoft) and Face-to-face supervision in people with Critical Incident, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study investigates the effectiveness of using Hololens2 for remote education and feedback in medical procedures, specifically central venous catheterization. HoloLens-based education offers realistic simulation and real-time feedback, enhancing learners' skills and providing a safe practice environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Incident
- What is being tested?
- Hololens2(Microsoft) and Face-to-face supervision
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2024to 2 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical personnel who require training in the specific medical procedure (central venous catheterization).
- Medical professionals who do not regularly use HoloLens 2 in their practice.
Who cannot join
- Individuals who do not consent to participate in this study. Those who regularly use HoloLens in their practice.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effectiveness of using Hololens2 for remote education and feedback in medical procedures, specifically central venous catheterization. HoloLens-based education offers realistic simulation and real-time feedback, enhancing learners' skills and providing a safe practice environment. This approach is expected to improve the efficacy of central venous catheter training and enhance healthcare professionals' abilities, thereby ensuring greater patient safety. The research aims to explore whether medical professionals can correctly perform procedures with remote guidance and feedback through Hololens2 and examines the potential of Head-Mounted Displays (HMDs) in medical education and their practical application in clinical settings.
Read the detailed description
This study is a Randomized Controlled Trial (RCT) comparing two groups regarding the supervision method in medical training:
- Face-to-Face Supervised Group: This group receives supervision in person.
- HoloLens 2 Supervised Group: Participants in this group receive supervision through content provided on HoloLens 2.
Medical professionals enrolled in the study will receive training in a specific surgical technique (C-line) using both supervision methods, with the order of training being randomly assigned. The study aims to investigate the validity of this training method. As part of the study, a brief survey will be conducted during the consent process.
The researchers will measure the total time taken for the training and the time taken for each step of the surgical technique. They will also use a standard Checklist to score the proficiency in performing the C-line technique. Additionally, the number of times the participants request assistance from the research supervisor will be recorded.
After the supervision, the effectiveness of each method will be assessed through survey questions. These questions will be administered both before and after the training (Pre-Post) to facilitate comparison.
Participants using HoloLens 2 will also undergo an interview about their experience using this technology, aiming to gather feedback on HoloLens 2.
Two weeks after the training, the clinical participants will perform the surgical technique again to assess their recall of the procedure. This performance will be evaluated using the Checklist.
All training sessions will be recorded on video, focusing on the hands and the model used for the surgical technique, without capturing identifiable facial features. These recordings will be used for timekeeping and analysis purposes and will be disposed of after the research concludes.
- Conditions
- Critical Incident
- Being tested
- Hololens2(Microsoft), Face-to-face supervision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hololens2(Microsoft)Device
Using Hololens as a Remote-teaching tool when supervising
Face-to-face supervisionBehavioural
Participants performed central venous catheterization on an ultrasound-compatible simulation model under conventional in-person supervision. A supervising physician was physically present to provide real-time verbal feedback and direct intervention, and a procedural manual was displayed on a laptop.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Supervision for participants in this group is provided through content delivered on intervention using HoloLens 2, a virtual reality technology.
The aim is to compare the effectiveness of VR-assisted learning with traditional face-to-face training methods.
Key measures include the time taken for training, proficiency in the surgical technique as per a standard Checklist, and the number of times participants seek assistance.
An important component of this group's experience is the interview regarding their experience using HoloLens 2, aiming to gather feedback on the VR technology.
The group's performance in recalling and executing the surgical technique after a two-week period is also assessed. Receives: Device: Hololens2(Microsoft) |
| Control group | Active comparator | Participants in this group receive supervision in person, which involves direct interaction with a supervisor during the training.
The focus of this group is to assess the effectiveness of traditional face-to-face training methods in imparting skills related to a specific surgical technique (C-line).
The training includes direct feedback, guidance, and real-time supervision from the trainer.
The efficiency of learning, time taken to master the technique, and the proficiency achieved are key aspects being measured.
Additional observations include the frequency of requests for assistance from the supervisor and the retention of the learned skills over a period of time. Receives: Behavioral: Face-to-face supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between Test and Control Group on the C-line procedure scores of pre and post test
The primary outcome of the study is the comparison of surgical technique checklist scores, as evaluated by the researchers and supervisors, between the pre-test and post-test for each group. This involves assessing the proficiency and skill development in the surgical procedure before and after the training, using a standardized checklist.
Measured: pre test and 2 week post test
Secondary outcomes (1)
Differences between Test and Control Group of the survery results
Scoring by the answers of the Questionnaire of the survey including Hololens SUS
Measured: pre test and 2 week post test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jan 2024
- Primary completion28 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IncidentStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taerim Kim, Doctoral, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861555
- Sponsor's protocol ID
- 2023-11-017
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be decided after the recruitment
Publications
Sivananthan A, Gueroult A, Zijlstra G, Martin G, Baheerathan A, Pratt P, Darzi A, Patel N, Kinross J. Using Mixed Reality Headsets to Deliver Remote Bedside Teaching During the COVID-19 Pandemic: Feasibility Trial of HoloLens 2. JMIR Form Res. 2022 May 17;6(5):e35674. doi: 10.2196/35674.
PubMed 35389347Robinson BL, Mitchell TR, Brenseke BM. Evaluating the Use of Mixed Reality to Teach Gross and Microscopic Respiratory Anatomy. Med Sci Educ. 2020 Aug 18;30(4):1745-1748. doi: 10.1007/s40670-020-01064-2. eCollection 2020 Dec.
PubMed 32837799
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Interactive Remote Supervising Platform for Critical Care: A Randomized Study
- ClinicalTrials.gov ID
- NCT07861555
- Acronym / sponsor ID
- 2023-11-017
- Conditions
- Critical Incident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 6 Oct 2026 (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.
This study investigates the effectiveness of using Hololens2 for remote education and feedback in medical procedures, specifically central venous catheterization. HoloLens-based education offers realistic simulation and real-time feedback, enhancing learners' skills and providing a safe practice environment. This approach is expected to improve the efficacy of central venous catheter training and enhance healthcare professionals' abilities, thereby ensuring greater patient safety. The research aims to explore whether medical professionals can correctly perform procedures with remote guidance and feedback through Hololens2 and examines the potential of Head-Mounted Displays (HMDs) in medical education and their practical application in clinical settings.
Detailed description
This study is a Randomized Controlled Trial (RCT) comparing two groups regarding the supervision method in medical training:
- Face-to-Face Supervised Group: This group receives supervision in person.
- HoloLens 2 Supervised Group: Participants in this group receive supervision through content provided on HoloLens 2.
Medical professionals enrolled in the study will receive training in a specific surgical technique (C-line) using both supervision methods, with the order of training being randomly assigned. The study aims to investigate the validity of this training method. As part of the study, a brief survey will be conducted during the consent process.
The researchers will measure the total time taken for the training and the time taken for each step of the surgical technique. They will also use a standard Checklist to score the proficiency in performing the C-line technique. Additionally, the number of times the participants request assistance from the research supervisor will be recorded.
After the supervision, the effectiveness of each method will be assessed through survey questions. These questions will be administered both before and after the training (Pre-Post) to facilitate comparison.
Participants using HoloLens 2 will also undergo an interview about their experience using this technology, aiming to gather feedback on HoloLens 2.
Two weeks after the training, the clinical participants will perform the surgical technique again to assess their recall of the procedure. This performance will be evaluated using the Checklist.
All training sessions will be recorded on video, focusing on the hands and the model used for the surgical technique, without capturing identifiable facial features. These recordings will be used for timekeeping and analysis purposes and will be disposed of after the research concludes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Hololens2(Microsoft)Supervision for participants in this group is provided through content delivered on intervention using HoloLens 2, a virtual reality technology. The aim is to compare the effectiveness of VR-assisted learning with traditional face-to-face training methods. Key measures include the time taken for training, proficiency in the surgical technique as per a standard Checklist, and the number of times participants seek assistance. An important component of this group's experience is the interview regarding their experience using HoloLens 2, aiming to gather feedback on the VR technology. The group's performance in recalling and executing the surgical technique after a two-week period is also assessed. |
| Control group | Active comparator | Behavioral: Face-to-face supervisionParticipants in this group receive supervision in person, which involves direct interaction with a supervisor during the training. The focus of this group is to assess the effectiveness of traditional face-to-face training methods in imparting skills related to a specific surgical technique (C-line). The training includes direct feedback, guidance, and real-time supervision from the trainer. The efficiency of learning, time taken to master the technique, and the proficiency achieved are key aspects being measured. Additional observations include the frequency of requests for assistance from the supervisor and the retention of the learned skills over a period of time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical personnel who require training in the specific medical procedure (central venous catheterization).
- Medical professionals who do not regularly use HoloLens 2 in their practice.
Key exclusion criteria (1 listed)
- Individuals who do not consent to participate in this study. Those who regularly use HoloLens in their practice.
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 |
|---|---|---|
| Hololens2(Microsoft)Using Hololens as a Remote-teaching tool when supervising | Device | Test group |
| Face-to-face supervisionParticipants performed central venous catheterization on an ultrasound-compatible simulation model under conventional in-person supervision. A supervising physician was physically present to provide real-time verbal feedback and direct intervention, and a procedural manual was displayed on a laptop. | Behavioural | Control group |
Primary outcome
Differences between Test and Control Group on the C-line procedure scores of pre and post test
Time frame: pre test and 2 week post test
The primary outcome of the study is the comparison of surgical technique checklist scores, as evaluated by the researchers and supervisors, between the pre-test and post-test for each group. This involves assessing the proficiency and skill development in the surgical procedure before and after the training, using a standardized checklist.
1 secondary outcome
Differences between Test and Control Group of the survery results
Time frame: pre test and 2 week post test
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 6 Oct 2026.
- Background: PubMed 35389347Sivananthan A, Gueroult A, Zijlstra G, Martin G, Baheerathan A, Pratt P, Darzi A, Patel N, Kinross J. Using Mixed Reality Headsets to Deliver Remote Bedside Teaching During the COVID-19 Pandemic: Feasibility Trial of HoloLens 2. JMIR Form Res. 2022 May 17;6(5):e35674. doi: 10.2196/35674.
- Background: PubMed 32837799Robinson BL, Mitchell TR, Brenseke BM. Evaluating the Use of Mixed Reality to Teach Gross and Microscopic Respiratory Anatomy. Med Sci Educ. 2020 Aug 18;30(4):1745-1748. doi: 10.1007/s40670-020-01064-2. eCollection 2020 Dec.
- Individual participant dataSharing planned: No. will be decided after the recruitment
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Heart Failure, Excessive Amount of Blood / Fluid Transfusion
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.
Taerim Kim, Doctoral principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hololens2(Microsoft) and Face-to-face supervision in people with Critical Incident, run by Samsung Medical Center at 1 site in South Korea.
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 6 Oct 2026. 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 South Korea. 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?
Differences between Test and Control Group on the C-line procedure scores of pre and post test (time frame: pre test and 2 week post test). 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 NCT07861555, which also lists 2 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 6 Oct 2026.