Emergency MedicineNCT05870137
Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment
A study testing HoloLens2TM in people with Emergency Medicine, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study assessed the feasibility and effectiveness of using Mixed Reality (MR) through the use of HoloLens2TM technology to enhance emergency clinical care delivery in a simulated environment. This was achieved by inviting 22 resident grade doctors to complete two scenarios. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine
- What is being tested?
- HoloLens2TM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2021to 26 Nov 2021
- 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
- All participants must provide consent to participate in the study
- Participants must receive a standardised HL2 headset and operational tutorial
- Participants must complete a qualitative questionnaire to determine their clinical experience and exposure to the technology prior to commencement of the study
- Participants must pass a competency test to ensure standardised basic technical competency and mitigate device related first-use learning effects
Who cannot join
- Not currently working in emergency medicine/trauma setting
- No prior course completion (Advance trauma and Basic Life support)
- Prior to the commencement of the study, all eligible participants were required to provide their consent to participate. Participants were then provided with a standardized HL2 headset and operational tutorial, and completed a qualitative questionnaire to assess their clinical experience and exposure to the technology. The tutorial, which was guided by the research team, included a practical induction providing fundamentals of use, how to make and receive calls, and how to use the clinical data assets provided. Participants were also required to pass a competency test to ensure standardized basic technical competency and mitigate device-related first-use learning effects.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Surgery and Cancer Imperial College London
London, W2 1NY
About this study
Official title: A Pilot Randomised Cross-over Trial of HoloLens2™️ for the Delivery of Distributed Medical Care During COVID-19 in a Simulated Environment.
This study assessed the feasibility and effectiveness of using Mixed Reality (MR) through the use of HoloLens2TM technology to enhance emergency clinical care delivery in a simulated environment. This was achieved by inviting 22 resident grade doctors to complete two scenarios. Each scenario was supported either by standard care methods or Mixed reality. The participants were randomised to at the start of the scenarios to determine which support they would receive first. The main outcome was to see if there was difference in error rates. This was assessed using the ICECAP multidimensional error capture tool. Secondary outcomes included teamwork, scenario completion, stress/cognitive load, and Mixed reality device user acceptability.
- Conditions
- Emergency Medicine
- Being tested
- HoloLens2TM, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoloLens2TMDevice
Participants assigned to Mixed Reality-supported care used the HoloLens2 device, which provided support using technology that was permitted by the device. This support included remote assistance and holographic versions of patient-specific investigation results, such as radiological findings, biochemistry, and guidelines for completing the procedure (insertion of chest drain).
Standard careOther
The standard care for the intervention involved participants performing the invasive technical procedure to treat a tension pneumothorax using their standard clinical skills and knowledge, without the aid of the HoloLens2 device. The participants in the standard care group did not receive any additional support or guidance beyond what is typically available in a clinical setting. The goal of the study was to compare the effectiveness of the standard care approach with the use of Mixed Reality-supported care using the HoloLens2 device.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Standard care was delivered by the participants with access to didactic instruction and telephonic support. Participants had access to all resources through standard ward base computer systems. Access to senior support through telephone call using a bleep/on call system standard to practice within the institution. Receives: Other: Standard care |
| Mixed reality - HoloLens2TM Supported care | Experimental | HL2 supported care made all of these resources available through interaction with the HL2 device. Participants had access to all resources through the Mixed reality device (HoloLens2). Access to senior support through using the HL2 device. Receives: Device: HoloLens2TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error Rate
The primary outcome measure for this study was the error rate, which was assessed using the ICECAP tool (Imperial College Error CAPture). This is a validated, multidimensional tool that assesses errors across several domains, including equipment, communication, technical aspects, patient-related factors, procedure-independent pressures, and a category for capturing any other errors that are not specified. Using the ICECAP tool provides a comprehensive assessment of errors and allows for identifying areas of improvement across multiple domains. Each time an error is observed the participant is attributed 1 score per error within the respective category. The total number of errors is accumulated throughout completion of the scenario. The error is reported as a sum of the total errors observed, as well as per category to determine if there is any specific areas that error rate is impacted.
Measured: Through study completion, an average of 8 minutes per scenario
Secondary outcomes (5)
Scenario completion success
The secondary outcome measure was the successful completion of the clinical scenario. This was determined by the simulation team assessing whether the participant was able to successfully insert the chest drain and complete a life-saving intervention in the simulated environment. If the participant was unable to appropriately insert the chest drain, this was considered an adverse outcome for the simulated patient, and thus the scenario was deemed unsuccessful.
Measured: Through study completion, an average of 8 minutes per scenario
Scenario completion duration
The secondary outcome measure was the time taken to complete the clinical scenario. This was recorded by the simulation team from the initiation of the scenario to the successful completion, which involved both the insertion of the chest drain and the completion of the intervention. If the participant expressed their desire to discontinue the intervention, this was also recorded as the endpoint of the scenario.
Measured: Through study completion, an average of 8 minutes per scenario
Team performance
The OTAS tool (Observational Teamwork Assessment for Surgery) is a validated scale that is commonly used to assess team performance in surgery. It is a structured observation tool that allows for the assessment of teamwork in the operating room setting, and it has been shown to have good inter-rater reliability and construct validity.
The tool can also be used to compare the performance of individual team members and to determine how the use of technology influences cognitive load and individual perspective performance. For example, studies have used the OTAS tool to evaluate the impact of laparoscopic surgery on team performance and to determine how the use of surgical robots affects teamwork and communication in the operating room.
Measured: Through study completion, an average of 8 minutes per scenario
Team performance
The T-SAW-C Tool (Teamwork Skills Assessment for Ward Care) was used by observers to assess teamwork during the simulated scenarios. This tool measures various aspects of teamwork, such as communication, coordination, and cooperation, and has been validated for use in healthcare settings. By including this information, it clarifies the measurement tool being used to assess the specific outcome measure of interest.
Measured: Through study completion, an average of 8 minutes per scenario
Team workload
The NASA Task Load Index (TLX) is a subjective multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance. It uses a Likert scale with six domains, each attributed a weight ranging from 0 to 5. The scale ratings are scored based on where the user marked the scale. Tick marks range from 0 to 100 by 5 point increments, and scores are given for the tick at or immediately above the mark. Higher scores indicate a greater perceived workload.
Measured: Through study completion, an average of 8 minutes per scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start17 Sep 2021
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised cross-over trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Kinross, PhD FRCS, Principal investigator, Senior Lecturer in Surgery and Consultant Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870137
- Sponsor's protocol ID
- 21SM6714
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lawson J, Martin G, Guha P, Gold M, Nimer A, Syed S, Kinross J. Effect of Mixed Reality on Delivery of Emergency Medical Care in a Simulated Environment: A Pilot Randomized Crossover Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330338. doi: 10.1001/jamanetworkopen.2023.30338.
PubMed 37639272
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Cross-over Trial of HoloLens2™️ for the Delivery of Distributed Medical Care During COVID-19 in a Simulated Environment.
- ClinicalTrials.gov ID
- NCT05870137
- Acronym / sponsor ID
- 21SM6714
- Conditions
- Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 23 May 2023 (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 assessed the feasibility and effectiveness of using Mixed Reality (MR) through the use of HoloLens2TM technology to enhance emergency clinical care delivery in a simulated environment. This was achieved by inviting 22 resident grade doctors to complete two scenarios. Each scenario was supported either by standard care methods or Mixed reality. The participants were randomised to at the start of the scenarios to determine which support they would receive first. The main outcome was to see if there was difference in error rates. This was assessed using the ICECAP multidimensional error capture tool. Secondary outcomes included teamwork, scenario completion, stress/cognitive load, and Mixed reality device user acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard careStandard care was delivered by the participants with access to didactic instruction and telephonic support. Participants had access to all resources through standard ward base computer systems. Access to senior support through telephone call using a bleep/on call system standard to practice within the institution. |
| Mixed reality - HoloLens2TM Supported care | Experimental | Device: HoloLens2TMHL2 supported care made all of these resources available through interaction with the HL2 device. Participants had access to all resources through the Mixed reality device (HoloLens2). Access to senior support through using the HL2 device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants must provide consent to participate in the study
- Participants must receive a standardised HL2 headset and operational tutorial
- Participants must complete a qualitative questionnaire to determine their clinical experience and exposure to the technology prior to commencement of the study
- Participants must pass a competency test to ensure standardised basic technical competency and mitigate device related first-use learning effects
Key exclusion criteria (3 listed)
- Not currently working in emergency medicine/trauma setting
- No prior course completion (Advance trauma and Basic Life support)
- Prior to the commencement of the study, all eligible participants were required to provide their consent to participate. Participants were then provided with a standardized HL2 headset and operational tutorial, and completed a qualitative questionnaire to assess their clinical experience and exposure to the technology. The tutorial, which was guided by the research team, included a practical induction providing fundamentals of use, how to make and receive calls, and how to use the clinical data assets provided. Participants were also required to pass a competency test to ensure standardized basic technical competency and mitigate device-related first-use learning effects.
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 |
|---|---|---|
| HoloLens2TMParticipants assigned to Mixed Reality-supported care used the HoloLens2 device, which provided support using technology that was permitted by the device. This support included remote assistance and holographic versions of patient-specific investigation results, such as radiological findings, biochemistry, and guidelines for completing the procedure (insertion of chest drain). | Device | Mixed reality - HoloLens2TM Supported care |
| Standard careThe standard care for the intervention involved participants performing the invasive technical procedure to treat a tension pneumothorax using their standard clinical skills and knowledge, without the aid of the HoloLens2 device. The participants in the standard care group did not receive any additional support or guidance beyond what is typically available in a clinical setting. The goal of the study was to compare the effectiveness of the standard care approach with the use of Mixed Reality-supported care using the HoloLens2 device. | Other | Standard care |
Primary outcome
Error Rate
Time frame: Through study completion, an average of 8 minutes per scenario
The primary outcome measure for this study was the error rate, which was assessed using the ICECAP tool (Imperial College Error CAPture). This is a validated, multidimensional tool that assesses errors across several domains, including equipment, communication, technical aspects, patient-related factors, procedure-independent pressures, and a category for capturing any other errors that are not specified. Using the ICECAP tool provides a comprehensive assessment of errors and allows for identifying areas of improvement across multiple domains. Each time an error is observed the participant is attributed 1 score per error within the respective category. The total number of errors is accumulated throughout completion of the scenario. The error is reported as a sum of the total errors observed, as well as per category to determine if there is any specific areas that error rate is impacted.
5 secondary outcomes
Scenario completion success
Time frame: Through study completion, an average of 8 minutes per scenario
Scenario completion duration
Time frame: Through study completion, an average of 8 minutes per scenario
Team performance
Time frame: Through study completion, an average of 8 minutes per scenario
Team performance
Time frame: Through study completion, an average of 8 minutes per scenario
Team workload
Time frame: Through study completion, an average of 8 minutes per scenario
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 23 May 2023.
- Derived from this study: PubMed 37639272Lawson J, Martin G, Guha P, Gold M, Nimer A, Syed S, Kinross J. Effect of Mixed Reality on Delivery of Emergency Medical Care in a Simulated Environment: A Pilot Randomized Crossover Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330338. doi: 10.1001/jamanetworkopen.2023.30338.
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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.
James Kinross, PhD FRCS principal investigator
Senior Lecturer in Surgery and Consultant Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoloLens2TM in people with Emergency Medicine, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 3 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 23 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 Kingdom. 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?
Error Rate (time frame: Through study completion, an average of 8 minutes per scenario). 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 NCT05870137, which also lists 1 linked publication.
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 23 May 2023.