Emergency Medicine
Conditions
Brief 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. 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.
Interventions
DEVICEHoloLens2TM
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).
OTHERStandard care
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.
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
To ensure masking in this clinical trial, the intervention sequence was randomized for each participant, and the assessors were kept blinded to the sequence. The assessors were not informed about which intervention was provided to each participant or which arm of the study each participant completed first. The trial achieved masking by randomly allocating participants to either the control or intervention groups and further by anonymizing the data after capturing the sequence, prior to releasing it to the outcome assessors. This approach ensured that the assessors were not biased in their assessments and were unaware of which intervention was provided to each participant. By blinding the assessors, the study was able to reduce potential sources of bias and increase the validity and reliability of the results. Overall, the masking approach used in this trial was designed to minimize the risk of bias and ensure that the results were as objective and accurate as possible.
Intervention model description
Randomised cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Error Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scenario completion success | Through study completion, an average of 8 minutes per scenario | 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. |
| Scenario completion duration | Through study completion, an average of 8 minutes per scenario | 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. |
| Team performance | Through study completion, an average of 8 minutes per scenario | 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. |
| Team workload | Through study completion, an average of 8 minutes per scenario | 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. |
Countries
United Kingdom
Outcome results
None listed