Comparing virtual reality simulation training for resuscitation after cardiac surgery with traditional classroom training
| ISRCTN | ISRCTN57122010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57122010 |
| Secondary identifying numbers | MEC-2022-0227, date 24-03-2022 |
- Submission date
- 12/10/2022
- Registration date
- 08/11/2022
- Last edited
- 29/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The cardiopulmonary resuscitation (CPR) protocol for patients who undergo open heart surgery through an incision (cut) in the middle of their chest differs from the conventional advanced life support protocol for other patients. These differences have led to the development of the Society of Thoracic Surgeons (STS) Cardiac surgery Advanced Life Support (CALS) protocol that has been widely adopted by cardio-thoracic surgical centres around the world. Adherence and prompt progression through these guidelines has shown to significantly improve outcomes in patients who experience cardiac arrest after cardiac surgery. Learning how to effectively manage such an arrest is difficult, principally because these events occur relatively infrequently, the time critical nature of the event, and the high cognitive load associated with this stressful situation, which impairs short-term memory performance and learning. Currently, the gold standard for CPR education is certified Advanced Life Support (ALS) training based on guidelines by the European Resuscitation Council (ERC). ALS training includes a plenary presentation on ALS and some exceptional ALS cases including for patients after cardiac surgery and several patient scenarios which are executed using a mannequin doll, and are evaluated based on the accuracy of the protocol by certified CPR trainers after which participants will receive a certificate.
Over the past few years, emerging virtual reality (VR) applications have quickly gained broad attention within the medical field, including in cardiology and cardio-thoracic surgery, as well as medical education more generally. Combining VR technology with head-mounted displays (HMD), enables the design of a realistic, custom-built simulation in a 3D fully immersive environment. Such a VR simulation (cardiopulmonary virtual reality simulator or CPVR-sim) was developed to train physicians and members of the multidisciplinary team for several CPR scenarios post-cardiac surgery. CPVR-sim enables the user to train themselves repeatedly and learn the steps described within the protocol in a realistic setting, without the need for other supplies or instructor-led training sessions. At present, only one study on the CPVR-sim has been conducted, to assess the face and content validity, which found that experts and their junior colleagues alike found this training method useful, easy to use, and would be suitable as an adjunct to additional training.
In order to assess the concurrent validity and effectiveness of this simulation, the aim is to perform the first randomized controlled trial (RCT) to show the value of CPVR-sim, compared with the gold standard of CPR training. It aims to impart the key differences between the standard ALS guidelines versus the ALS guidelines post-cardiac surgery, the components of the STS protocol, and other clinical insights regarding the management of post-cardiac surgery arrests.
The aim is to show that participants who undergo VR training will be able to progress through the algorithm accurately and as quickly as participants who only undertake the traditional training, thereby demonstrating the utility of the CPVR-sim. This trial will therefore compare the scores and timing of predefined clinical endpoints and technical steps, based on the international guidelines between the control group (gold standard training) and the intervention group (CPVR-sim).
Who can participate?
Trainee heart surgeons in the Netherlands who have more than 1 year of experience
What does the study involve?
Participants will be divided into two groups, where one group will undergo VR training and the other will undergo conventional classroom teaching followed by a practical teaching session using a resuscitation doll. The researchers will then compare the performance of these two groups using the aforementioned doll in a physical test scenario. They will time the participants and see how long it takes to reach specific points in the cardiac surgery resuscitation algorithm. They will also monitor if they make any mistakes or do any steps in the wrong order.
What are the possible benefits and risks of participating?
It is expected that participants will gain a better knowledge of the cardiac surgery resuscitation protocol and thereby deliver better patient care. There is a small risk of physical injury when performing the physical assessment due to overexertion, or inappropriate handling of sharp instruments, which will be left sheathed for the purposes of the assessment.
Where is the study run from?
The study is run from the Erasmus Medical Centre, but the training day will be held at QTTime in Houten, The Netherlands, where they have the appropriate resuscitation simulation equipment.
When is the study starting and how long is it expected to run for?
January 2022 to November 2022
Who is funding the study?
1. Erasmus MC (Netherlands)
2. The junior association of cardiothoracic surgeons in the Netherlands
3. Gettinge group (Sweden)
Who is the main contact?
Dr Edris Mahtab, e.mahtab@erasmusmc.nl
Contact information
Principal Investigator
Dr. Molewaterplein 40
Rotterdam
3015GD
Netherlands
 ORCID ID |
0000-0003-2647-5509 |
|---|---|
| Phone | +31 (0)107040704 |
| e.mahtab@erasmusmc.nl |
Study information
| Study design | Single-centre interventional single-blinded randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | 42592_PIS_V1_24Mar22.pdf |
| Scientific title | Virtual reality simulator versus conventional advanced life support training for cardiopulmonary resuscitation post-cardiac surgery: a randomized controlled trial |
| Study acronym | CPVR-RCT |
| Study objectives | A Virtual Reality Simulator for Advanced Life Support after Cardiac Surgery performs comparably to the gold standard of classroom and moulage Advanced Life Support Training in preparing residents for cardiac arrest situations after cardiac surgery requiring resternotomy. |
| Ethics approval(s) | Approved 24/03/2022, Medical Ethics Review Committee Erasmus MC (Dr. Molewaterplein 40 3015 CD Rotterdam, The Netherlands; +31 (0)10 7033625; metc@erasmusmc.nl), ref: MEC-2022-0227 |
| Health condition(s) or problem(s) studied | Patients who experience cardiac arrest after cardiac surgery |
| Intervention | Participants will be randomized using the Castor software package (Civit B.V., Amsterdam, The Netherlands). The randomisation strategy is block randomisation, using blocks of 4, based on the level of experience of each participant, defined as junior (<4 years), and senior (>4 years), such that the distribution of experience in both groups is roughly equal. Participants in the control group will receive standard ALS training specifically for patients with cardiac arrest after cardiac surgery, from a certified ALS instructor. This training included a presentation of the protocol (±15 minutes) and simulation training (±45 minutes) with a resternotomy manikin (CSU-ALS 4th generation manikin, CALS, UK). Participants in the VR group first will receive a short (± 5 min) introductory briefing on how the VR headset and controllers work. Next, they will undergo CPVR-sim simulation training including three different (ventricular fibrillation/pulseless electrical activity/asystole) patient cases. This CPVR-sim will take an estimated ±30-45 minutes to complete per participant, depending on their skills and experience with VR/gaming and their knowledge of the CPR protocol. |
| Intervention type | Other |
| Primary outcome measure | 1. Successfully delivered three shocks within a given moment (1 minute) during the training 2. Successfully performed resternotomy within a given moment (5 minutes) during the training |
| Secondary outcome measures | 1. Protocol deviations, defined as incorrect order of actions, missed steps, or incorrect execution of an action during the training 2. The time to specific actions that should be performed as part of the CALS algorithm stated in the international guidelines |
| Overall study start date | 01/01/2022 |
| Completion date | 01/11/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 31 |
| Key inclusion criteria | 1. CTS residents in the Netherlands 2. Have at least 1 year of experience in cardiothoracic surgery. This data will be taken from a baseline questionnaire about their work experience in the field of CTS, cardiac arrest in patients after cardiac surgery, and (emergency) resternotomies 3. Participants must provide informed consent in order to be eligible to participate in this study 4. There are no age criteria |
| Key exclusion criteria | 1. Not able to partake in the conventional or VR training 2. Not able to perform the physical assessment 3. Fail to provide informed consent |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 17/05/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rotterdam
3015GD
Netherlands
Sponsor information
Hospital/treatment centre
Dr. Molewaterplein 40
Rotterdam
3015GD
Netherlands
| Phone | +31 (0)107040704 |
|---|---|
| info@erasmusmc.nl | |
| Website | https://www.erasmusmc.nl/en/ |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
No information available
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers plan to publish in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request for participants only, and they will only be able to access data pertaining directly to themselves, in accordance with GDPR. Anonymised data will be available for audit by relevant public bodies, and/or research integrity organisations, solely for the purposes of auditing the study. Name: Jette J. Peek Email: j.j.peek@erasmusmc.nl The data will available for audit for a maximum period of 15 years after the conclusion of the study. Informed consent will be gained from each participant prior to participation in any trial-related activity. Participant data will be anonymised, with a key available to de-anonymise should this be required for audit purposes. There are no other relevant legal or ethical restrictions regarding our participant data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 24/03/2022 | 13/10/2022 | No | Yes |
| Results article | 04/02/2023 | 29/12/2023 | Yes | No |
Additional files
Editorial Notes
29/12/2023: Publication reference added.
13/10/2022: Trial's existence confirmed by the Medical Ethics Review Committee Erasmus MC.
