Training Healthcare Professionals in an Artificial Intelligence Based Virtual Reality Extracorporeal Membrane Oxygenation Simulator Versus Conventional Video Training; a Multicentre Feasibility Study and Randomised Controlled Trial
Phase: NA
Conditions: ECMO, Training Effectiveness, Education Nursing, Educational Intervention, Virtual Reality, Simulation Based Medical Education, Simulation Training
Sponsor: Leiden University Medical Center

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Study Title: Training Healthcare Professionals in an Artificial Intelligence Based Virtual Reality 
Extracorporeal Membrane Oxygenation Simulator Versus Conventional Video Training; a Multicentre 
Feasibility Study and Randomised Controlled Trial 
Protocol ID: MEC-2023-0666 
 
NCT Number: not yet allocated. 
 
Document Date: 12th of October 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TEMPLATE RESEARCH PROTOCOL 
for non-WMO-applicable research 
 
 
Template 19-01-2023, versie 2 
 
 
 
 
 
 
 
 
 
 
 
 

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Full title of protocol  
Training Healthcare Staff to Use an Extracorporeal 
Membrane Oxygenator Circuit in Virtual Reality; a 
Randomised Controlled Trial 
Short title or Acronym 
HEALTH-ECMO-VR-RCT 
Protocol ID / Panama number 
11261 
Version 
V1.0 
Date 
12/10/2023 
Coordinating investigator1/ 
Project leader 
Drs. Samuel Max – Arts Promovendus (Physician and PhD 
Candidate) 
s.max@erasmusmc.nl 
Student Investigator  
Priscilla Westbroek – Klinisch Perfusionist in opleiding 
p.westbroek@erasmusmc.nl 
Principal investigator2 
 
 
Dr. Edris Mahtab – Cardiothoracale Chirurg (Cardiothoracic 
Surgeon) 
e.mahtab@eramusmc.nl 
Sponsor4 (in Dutch: 
verrichter/opdrachtgever) 
Erasmus MC 
Subsidizing party5 
Erasmus+ Grant 2022-1-NL01-KA220-HED-000087770 
LUMC Fellowship Grant 2023 
 
Name 
Signature 
Date 
Head of Department: 
Prof. Dr. J (Jolanda) Kluin MD PhD 
Head of Department 
(Head of Cardiothoracic Surgery Department) 
 
 
Project Leader: 
Drs. S. A. Max – Physician / PhD Candidate 
Principal Investigator: 
Dr. E. A. F. Mahtab – Cardiothoracic Surgeon  
 
 
 
 
 
1. 
Coordinating investigator: Investigator who bears the responsibility for the coordination of investigators operating in the 
various centers participating in multicenter research. Not all multicenter research will have a coordinating investigator. 
There is no requirement to appoint one. A project leader has the responsibility to develop a research protocol and to 
complete the study within the predefined goals. 
2. 
Principal investigator: Investigator who has the overall responsibility to comply and to complete the study within the 
predefined goals. 
3. 
Multicenter research: as an alternative you can also state that these are specified in the list with participating centers 
including principal investigator. This separate document with version date must be uploaded under category I1.    

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4. 
Sponsor: The party that commissions the organization or performance of the research, for example a pharmaceutical 
company, academic hospital, scientific organization or the investigator’s employee. A party that provides funding for a 
study but does not commission it is not regarded as the sponsor, but referred to as a subsidizing party. 
5. 
Subsidizing party: A party that provides funding for a study but does not commission it 
 
Table of Contents 
 
List of abbreviations and relevant definitions ................................................................................. 5 
Summary ......................................................................................................................................... 6 
 
Introduction and rationale .................................................................................................... 9 
 
Objective(s) .......................................................................................................................... 9 
 
Study type ............................................................................................................................ 9 
 
Study population .................................................................................................................11 
 
Methods ............................................................................................................................. 12 
 
Incidental findings .............................................................................................................. 12 
 
Statistical analysis ............................................................................................................. 12 
 
Ethical considerations ........................................................................................................ 13 
 
Handling and storage of data / images / sound recordings / photos / film recordings ..... 14 
 
Handling and storage of human material ....................................................................... 15 
 
Exchange, sharing or transfer of data and/or human material and/or images.............. 16 
 
Amendments .................................................................................................................. 16 
 
End of study report  ........................................................................................................ 16 
 
Publication ...................................................................................................................... 16 
 
References ..................................................................................................................... 16 
 
Attachments ................................................................................................................... 17 
 
 
Please note that it is not allowed to remove paragraphs from this template protocol. If a paragraph is 
not applicable, please mention this in the specific paragraph, preferably with a short motivation.  

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List of abbreviations and relevant definitions* 
 
CTA 
Clinical Trial Agreement 
De novo biobank 
A new data, human material or imaging collection 
DMP 
Data Management Plan 
DPIA 
Data Protection Impact Assessment 
DTA 
Data Transfer Agreement 
Exception consent 
Form Care for data Template, in Dutch: Formulier uitzondering toestemming 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation in Dutch: Algemene Verordening 
Gegevensbescherming 
IC 
Informed Consent 
IFU 
Instruction For Use 
MTA 
Material Transfer Agreement 
NWTC 
Non-WMO Review Committee; in Dutch: Niet WMO Toetsingscommissie 
UAVG 
Dutch Act on Implementation of the General Data Protection Regulation; in 
Dutch: Uitvoeringswet Algemene Verordening Gegevensbescherming 
WMO 
Medical Research Involving Human Subjects Act, in Dutch: Wet Medisch-
wetenschappelijk Onderzoek met Mensen 
 
*Please add any new definitions that are used in the research protocol 
 
 
 
 
 
 
 

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Summary 
 
The summary should give a brief description of the central question that the research is intended to 
answer and its justification. It should specify the hypothesis (if applicable) and the research objectives. In 
addition, the synopsis should briefly describe the design, population, methods and procedures of the 
study. Finally, if applicable, the nature and extent of the burden and risks should be indicated.  
Rationale 
For intensive care staff in training, learning the steps in monitoring the function of an extracorporeal 
membrane oxygenator (ECMO) machine are fundamental concepts that form the basis on which their 
future practice will be built. The modality of this training is often practical in the form of an apprenticeship, 
shadowing experienced intensivists or perfusionists in order to learn their craft. We propose that if this 
initial training required more active participation in the form of a simulation, that trainees would learn 
these procedures more quickly and more reliably.  
Over the past few years, emerging virtual reality (VR) applications have quickly gained broad attention 
within the medical field, including in cardiology and cardiothoracic 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 3 dimensional fully immersive environment [1]. Our group has 
developed a Virtual Reality (VR) simulation of the process of monitoring and performing a full circuit check 
for an ECMO patient. This Virtual Reality Extracorporeal Membrane Oxygenator Simulator (VR-ECMO 
sim) promises to update how we approach education of perfusionists and intensive care staff for their 
critical role. 
In a related study on the VR-Extracorporeal Simulator (entitled “Virtual Reality Simulation as a Training 
Tool for Perfusionists in Extra Corporeal Circulation; Establishing Face and Content Validity” currently 
under peer-review), we showed that experts and novices alike found the simulator to be useful & realistic, 
and therefore valid for face and content validity. Due to the demonstration of feasibility in a closely related 
simulator, we aim to demonstrate face and content validity alongside concurrent validity in a single study 
for the VR-ECMO sim. We hypothesise that VR will enable participants to better learn and retain 
information through interactive engagement with a virtual reality simulator. 
Objective(s) 
Primary outcomes 
The accuracy with which the predefined sequence of steps is performed by the participant, defined as 
number of mistakes made and time taken, and amount of prompts/assistance required from the expert 
perfusionist. 
Secondary outcomes 
Additional data include participants views on the advantages and disadvantages of virtual reality training 
in the context of ECMO. 
Additional study parameters 
Data will be collected on the participants age, gender, experience with ECMO, and experience with VR 
usage.   
Study type 
This will be a hybrid study, with an expert & novice face & content study, and contained within the novice 
group, a single blinded randomised controlled trial. 

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Study population 
Our study will recruit from two populations for the expert and novice arms of this study. For the former, 10 
experts who are experienced perfusionists/intensivists with more than 6 years of experience with ECMO 
will be included. For the novice arm, the population will include intensive care nurses & cardiothoracic 
surgery nurses who work at one of the academic hospitals in the Netherlands, with no prior experience 
with ECMO. 
 
Methods 
The study is broadly divided into two arms: expert (experienced perfusionists / intensive care staff) and 
novices (Intensive care staff who have no experience with ECMO) and is summarised in Figure 1. 
Novice Arm (Randomised Controlled Trial) 
 
Novice participants will be allocated a study ID from 1-50 at the point of recruitment and randomised by 
an online research randomiser (https://www.randomizer.org/) between the instructional video (control) 
group and VR-ECMO sim (intervention) group. The control group will watch a video in which a 
perfusionist explains how to perform a circuit check for an ECMO patient on VA ECMO. The participants 
are then individually assessed using a real ECMO machine and ECMO doll, whereby they are asked to 
repeat the steps that they have been trained in. This assessment is recorded on video to be assessed 
later by an expert assessor, and an expert perfusionist & assessor will be present during the assessment 

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to provide prompts when a student is unsure how to perform a certain step. After completion of the 
assessment, the VR group will be asked to fill out an objective questionnaire (Appendix 2) based on the 
standardised USE questionnaire [2] to assess baseline characteristics such as prior experience/training 
and the usefulness, satisfaction, and ease of use of the VR training modality. Participants from the control 
group will be given the option to also perform the VR training, and subsequently fill a USE questionnaire 
about their experience with VR. 
Expert Arm 
Expert participants will not be randomised, and will all perform the VR-ECMO sim before completing the 
USE questionnaire. Their data will be used for the face and content validity portion of this study. 
Randomisation 
Participants in the novice arm will be randomly assigned to either interventional or control group, using 
https://www.randomizer.org/ as stated above to generate a group allocation for the participant according 
to their study ID number.  
Blinding 
Participants will not be blinded as the differences in the differing nature of the intervention versus control 
group do not allow for this. Selected study personnel, including those physically facilitating both groups 
during the intervention phase will not be blinded, as again the study design does not allow for this. Study 
personnel who facilitate the physical assessment for the novice arm, perform data collection & analysis, 
including the expert assessor for the video recording, will be blinded. 
 
Burden and risks 
We do not foresee any risks or burdens incurred with participation, aside from mild nausea which may 
occasionally occur during a virtual reality experience. This typically subsides quickly once the head 
mounted display is removed. 
Recruitment and consent 
Our study will recruit from two populations for the expert and novice arms of this study. For the former, 10 
experts who are experienced perfusionists/intensivists with more than 6 years of experience with ECMO 
will be included. For the novice arm, the population will include intensive care nurses & cardiothoracic 
surgery nurses who work at one of the academic hospitals in the Netherlands, with no prior experience 
with ECMO. We calculated a required sample size of 44 novice participants (22 per group) in order to 
likely achieve statistically significant results. 
The recruitment process will be performed by a combination of poster advertisements featuring a QR 
could where participants can sign up. These posters will be hung in areas where eligible staff are likely to 
gather e.g. break rooms. On the sign-up page, the participants will be asked to enter name and contact 
details, and then will be presented with the participant information form as attached as an appendix to this 
application. Once they have read this sheet, and agreed to it in the form by selecting ‘I wish to participate’ 
from multiple choice question, they will be taken to a further webpage where the option will be given to 
select a date on which to participate  
 
 
 
 

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 Introduction and rationale 
For intensive care staff in training, learning the steps in monitoring the function of an extracorporeal 
membrane oxygenator (ECMO) machine are fundamental concepts that form the basis on which their 
future practice will be built. The modality of this training is often practical in the form of an 
apprenticeship, shadowing experienced intensivists or perfusionists in order to learn their craft. We 
propose that if this initial training required more active participation in the form of a simulation, that 
trainees would learn these procedures more quickly and more reliably.  
 
Over the past few years, emerging virtual reality (VR) applications have quickly gained broad attention 
within the medical field, including in cardiology and cardiothoracic 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 3 dimensional fully immersive environment [1]. Our 
group has developed a Virtual Reality (VR) simulation of the process of monitoring and performing a 
full circuit check for an ECMO patient. This Virtual Reality Extracorporeal Membrane Oxygenator 
Simulator (VR-ECMO sim) promises to update how we approach education of perfusionists and 
intensive care staff for their critical role. 
 
In a related study on the VR-Extracorporeal Simulator (entitled “Virtual Reality Simulation as a Training 
Tool for Perfusionists in Extra Corporeal Circulation; Establishing Face and Content Validity” currently 
under peer-review), we showed that experts and novices alike found the simulator to be useful & 
realistic, and therefore valid for face and content validity. Due to the demonstration of feasibility in a 
closely related simulator, we aim to demonstrate face and content validity alongside concurrent validity 
in a single study for the VR-ECMO sim. We hypothesise that VR will enable participants to better learn 
and retain information through interactive engagement with a virtual reality ECMO simulator versus 
conventional training. 
 Objective(s) 
In this study, the goal is to assess the face, content, and concurrent validity of the VR-ECMO sim by 
comparing the questionnaire ratings of novices and experts after completing the VR-ECMO sim, and 
comparing the novice intervention group who completed the VR-ECMO sim versus the control arm 
(video training) in terms of how well they are able to perform an ECMO circuit check, as rated by an 
expert. 
 Study type 
 
3.1. Study type  
 
☐ Retrospective 
☒ Prospective 
☐ Combination Retrospective/Prospective 
 
3.2.  Single center / Multicenter 
 
☐ Single center 
☒ Multicenter 
 
3.3  Check all the applicable boxes 
 
☐ Medical records (re-use of data from healthcare, including AI) 

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☐ Case report 
☐ Re-use data from research 
☐ Evaluations of quality of healthcare (retrospective 
☐ Research with additional use of residual material from regular healthcare 
☐ Research with re-use of human material from research or existing biobank 
☐ De novo biobank 
☐ Phase IV research 
☐ Healthcare evaluation research (prospective) 
☐ Research with medical devices 
☐ Research with In Vitro Diagnostic Tests 
☒ Other research, describe 
Research with medical professionals comparing a new educational simulator with an educational 
video 
 
 
 
 
 

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 Study population 
 
4.1. Study population 
 
☒ Adults (16 years and older) 
☐ Minors (younger than 16 years) 
☐ Incapacitated adults (16 years and older) 
☐ Incapacitated minors (younger than 16 years) 
 
4.2. Population (base)  
As above; Our study will recruit from two populations for the expert and novice arms of this study. 
For the former, 10 experts who are experienced perfusionists/intensivists with more than 6 years 
of experience with ECMO will be included. For the novice arm, the population will include 
intensive care nurses & cardiothoracic surgery nurses who work at one of the academic hospitals 
in the Netherlands, with no prior experience with ECMO.  
 
4.3. Inclusion criteria 
Novices Inclusion Criteria 
In order to be eligible as participant in this study in the Novice Arm, a subject must meet the following 
criteria:  
1. 
Currently working as a nurse in one of the academic hospitals in the Netherlands 
2. 
Provide informed consent 
 
Experts Inclusion Criteria 
In order to be eligible as participant in this study for the Expert Arm, a subject must meet the following 
criteria:  
1. 
Currently working as an intensivist or perfusionist in one of the academic hospitals in the 
Netherlands 
2. 
Provide informed consent 
 
 
4.4 
Exclusion Criteria  
Novices Exclusion criteria 
1. Failure to provide informed consent 
2. Previous experience with ECMO equipment 
3. Any reason that participants may not be able to perform the physical assessment 
Experts Exclusion criteria 
1. 
Failure to provide informed consent 
2. 
Less than 6 years’ experience with ECMO 
 
4.5 
Sample size calculation 

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We calculated a required sample size of 32 novice participants (16 per group) in order to likely 
achieve statistically significant results in the Novice RCT arm. This is based on an alpha of 0.05, 
beta of 85, and a mean difference of 1. The expert group requires 10 participants in order to 
reasonably assess the face & content validity. 
 Methods 
 
5.1. Research methods 
Data will be extracted using online questionnaires. These questionnaires will be built in 
Microsoft Forms, the results from which are sorted in Microsoft Sharepoint. In this way, results 
are automatically added when a form is completed, and assigned to the correct row using the 
participant’s study ID, assigned to them once they are recruited. Video footage of the physical 
assessments will be filmed with a camera, before the footage is locally stored on the V drive, 
and also a backup of the footage is made in Sharepoint. 
 
Once the study is complete, an archive of the study data will be created, and stored for 10 years 
using the facilities afforded to us by the Erasmus MC. 
 
5.2. Standard clinical care versus extra for research  
N/A 
 
5.3. Burden and risks 
Aside from mild nausea which may occasionally occur during a virtual reality experience,wWe 
do not foresee any risks or burdens incurred with participation. Any nausea typically subsides 
quickly once the head mounted display is removed. 
 
5.4. Medical device(s) / In vitro diagnostic tests 
N/A 
 
 Incidental findings 
 
6.1. 
Chance of incidental findings 
Is there a chance of incidental findings? 
☐ Yes 
☒ No 
 
6.2. 
Procedures 
If yes, describe who will be notified and how the subjects and other parties will be notified in 
case of incidental findings from the study that may be in the interest for the participant’s health. 
 
 Statistical analysis 
Describe how data will be analyzed 
 
7.1 Main study parameters/endpoints 
The accuracy with which the predetermined sequence of steps involved in an ECMO circuit check is 
performed by the participant. This is defined as number of mistakes made, and amount of 
prompts/assistance required from the expert perfusionist present at the assessment. Additionally, time to 

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accurately perform the predetermined endpoints/steps in the protocol of performing a circuit check as 
defined in Appendix 3. 
 
7.2 
Secondary study parameters/endpoints 
 
 
USE questionnaire (Appendix 2) to include participant ratings on the perceived usefulness, satisfaction, 
ease of use, and level of immersion of the VR-ECMO sim. Additional data include participants views on 
the advantages and disadvantages of virtual reality training in the context of ECMO. 
 
7.3 
Other study parameters 
 
Data will be collected on the participants age, gender, experience with ECMO, and experience with VR 
usage.   
 
7.4 
Analysis 
Please describe how the analysis will be done for the outcome parameters. 
 
R version 4.2.2 will be used for analysis. Continuous data will be assessed for normal distribution using a 
Q-Q plot and Shapiro Wilk test. The data will be described as median (IQR) or means (SD) and compared 
using either an unpaired t-test or the Mann-Whitney U test (whichever is appropriate according to the 
distribution) will be used to determine significance. Categorical variables will be reported as numbers (%) 
and compared using a chi-squared test or fishers exact test (whichever is appropriate according to the 
distribution). All baseline characteristics and outcome data will be compared using abovementioned tests. 
In case of confounding variables, we will correct for these using Analysis of Covariance (ANCOVA). A P-
value of <.05 will be considered statistically significant. 
 Ethical considerations 
 
8 
Regulation statement 
The study will be conducted according to the principles of the Declaration of Helsinki (64th WMA 
General Assembly, Fortaleza, Brazil, October 2013), Gedragscode Gezondheidsonderzoek 2022 and 
in accordance with ISO 27799:2016(en) standards, regulations and Acts. 
 
8.1 
Informed consent 
Will the subjects be asked for informed consent? 
☒ Yes (Upload Participant Information Letter and Informed Consent) 
☐ No, consent already given in previous study (Upload Participant Information Letter and 
Informed Consent previous study) 
☐ No, this research will be performed under the exception consent (Upload form Care for data 
Template, in Dutch: Formulier uitzondering toestemming) 
☐ Other (e.g. partly, indirectly) Please describe the situation. 
 
8.2 
Recruitment and informed consent procedures 
If yes, please give a description of the recruitment and informed consent procedures. How and 
by whom (investigator, supervising doctor, other person) participants will be informed about the 

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study and asked for their consent, how much time will they be given to consider the decision. 
The patient information letter with informed consent form should be attached as a separate 
document. 
The recruitment process will be performed by a combination of poster advertisements featuring a QR 
code where participants can sign up. These posters will be hung in areas where eligible staff are likely to 
gather e.g. break rooms. On the sign-up page, the participants will be asked to enter name and contact 
details, and then will be presented with the participant information form as attached as an appendix to this 
application. Once they have read this sheet, and agreed to it in the form by selecting ‘I wish to participate’ 
from multiple choice question, they will be taken to a further webpage where the option will be given to 
select a date on which to participate  
 
8.3 
Exception consent 
N/A  
 Handling and storage of data / images / sound recordings / photos / film recordings 
 
Data / images / sound recordings / photos / film recordings 
Please describe which data / images / sound recordings / photos / film recordings is/are used, 
are they obtained for regular healthcare purposes or in the context a research project, or a 
combination. 
 
In line with Erasmus MC guidelines, all video footage recordings will be kept 10 years after it is 
collected. The videos of the assessments will be stored on Microsoft Sharepoint, with filenames 
labelled only with the participants’ study ID. Only the PI, research coordinator, and the expert 
who will assess the videos will be granted access to them. 
 
9.1 
Privacy protection 
Describe how subject’s privacy is protected. Describe how, when and by whom data is coded 
(unique code without initials or date of birth) and how the key table is safeguarded, mention the 
General Data Protection Regulation. 
The handling of data will comply with the EU General Data Protection Regulation and the Dutch Act on 
Implementation of the General Data Protection Regulation (in Dutch: Algemene Verordening 
Gegevensbescherming en Uitvoeringswet Algemene Verordening Gegevensbescherming. A key table 
is produced and stored on Microsoft Sharepoint with only the PI and Research Coordinator who will be 
granted access to it. The rest of the data is stored in a separate table containing no identifiable 
personal information. The latter database includes all of the data from the questionnaires and the 
results from the assessments. The final data include the videos of the assessment, which stored on 
sharepoint, labelled only with the participants study ID. Only the PI, research coordinator, and the 
expert who will assess the videos will be granted access to them.  
9.2 
Handling and storage of data 
Describe how data is handled and stored (i.e., which data management system/data capture 
system), anonymous / pseudonymized / coded / identifiable, who has access to the coded 
source data, how long data will be kept, which steps are taken to ensure data security, what 
happens with the data after the research has been completed. 
 
Each pseudonymised participant data set will be assigned a study number known by the investigator. 
Using these coded study numbers, offline data will be stored using SPSS. Data will be stored on an 
Erasmus MC local network drive with automatic overnight back-up. Stored data regarding anonymous 
data sets and personnel included in this study can only be accessed by the investigators, the 
Erasmus MC ethics committee, Erasmus MC auditors and Erasmus MC monitors and any person or 

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agency required by law like the “Inspectie voor de Gezondheidszorg”. All data will be treated 
according to the “Wet Bescherming Persoonsgegevens” and the Erasmus MC privacy regulations. 
Any information from this study, if published in scientific journals or presented at scientific meetings, 
will not reveal participant identity. Data will be stored for a minimum of 10 years according to Erasmus 
MC guidelines, and a maximum of 15 years after ending the study. Collected data will be secured 
against unauthorised access and will be stored and secured by the department of Cardiothoracic 
Surgery. 
 
9.3 
Handling and storage of images / sound recordings / photos / film recordings 
Describe how images / sound recordings / photos / film recordings are handled and stored, how 
the subject’s privacy is protected, anonymous / pseudonymized / coded / identifiable, what 
happens with images after the research has been completed. 
 
 As above, the videos of the assessment will be stored on Microsoft Sharepoint, labelled only with the 
participants study ID. Only the PI, research coordinator, and the expert who will assess the videos will be 
granted access to them. After the completion of the study, in line with Erasmus MC guidelines, all video 
footage recordings will be kept 10 years after they are collected, and will be destroyed after 10 years.  
 
9.4 
Approval of access to data / images / sound recordings / photos / film recordings 
Describe how the access is approved. Is access granted by the Data Board, Department, 
Principal investigator of the collection or other?  
Access is determined by the primary research team (PI + Project Coordinator), and only members of the 
research team and any authorized audit bodies may access the video recordings. 
 Handling and storage of human material 
 
10.1 Human material 
N/A 
 
10.2 Check all the boxes which are applicable to the human material origin: 
☐ Residual material from regular healthcare 
☐ Research (material acquired from a previous study).  
Add the reference of the study i.e., MEC-number Erasmus MC. 
☐ Re-use of human material from existing biobank 
      Describe whether the human material originates from research into the same disease.  
☐ Other, please specify 
 
10.3 Handling and storage of human material  
☐ Anonymous, i.e. the material can never be traced back to an individual subject 
☐ Pseudonymized/Coded 
☐ Identifiable 
 
Describe how human material is handled and stored (i.e. which data management system / data 
capture system), anonymous / pseudonymized / coded / identifiable, who has access to the 
human material, how long the human material will be kept,  what happens with the data after the 
research has been completed. 

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In line with Erasmus MC guidelines, human material will be kept 10 years after it is collected. 
 
10.4 Biobank 
In case of new human material collection (biobank), describe how the human material is coded 
and stored (which registration system, Central Biobank or other location), who has access to the 
registration system and human material, by whom the key to the code is safeguarded, how  
long and where human material will be kept, what happens to the human material when the 
storage period is expired. 
 
10.5 Approval of access to human material 
Describe how the access is approved. Is access granted by the Department, Principal 
investigator of the collection or other?. 
 
  Exchange, sharing or transfer of data and/or human material and/or images 
Describe with which organization the data and/or human material and/or images are shared, are they 
profit or non-profit organizations, whether these organizations are in the EU or outside the EU, how 
the privacy of subjects is protected outside the Erasmus MC and describe the procedures regarding 
the exchange(s), whether a Data Transfer Agreement/Material Transfer Agreement is available (if 
yes, please upload the DTA/MTA). 
 
N/A 
 
 Amendments 
Any amendments of alterations to the study in terms of overall study design, intervention, or analysis will 
be submitted to the METC for approval, and participants notified where necessary. Substantial 
amendments must be approved by the Niet WMO Toetsingscommissie before they can be implemented. 
 
 End of study report 
Within one year after the end of the study a final study report will  be submitted with the results of the 
study, including any publications/abstracts of the study. 
 
This will be completed one year after the conclusion of the study. 
 
 Publication 
Do you have the intention to submit the study results in a manuscript for publication in a journal: 
☒ Yes  
☐ No, please motivate 
 
Describe when the final study report with the results of the study will be submitted. 
We aim to have the results analyzed and published by March 2024 
 References 
Include a list of all key references published in peer review journals that are relevant for the study 
and are discussed in the protocol 
 

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1. 
Sadeghi A, Peek J, Max S, Smit L, Martina B, Rosalia R, Bakhuis W, Bogers A, Mahtab E. Virtual 
Reality Simulation Training for Cardiopulmonary Resuscitation After Cardiac Surgery: Face and 
Content Validity Study JMIR Serious Games 2022;10(1):e30456 URL: 
https://games.jmir.org/2022/1/e30456 DOI: 10.2196/30456  
 
2. 
 Lund A. Measuring Usability with the USE Questionnaire. Usability and User Experience 
Newsletter of the STC Usability SIG. 2001;8. 
 
3. 
Dankbaar MEW, Richters O, Kalkman CJ, Prins G, ten Cate OTJ, van Merrienboer JJG, et al. 
Comparative effectiveness of a serious game and an e-module to support patient safety 
knowledge and awareness. BMC Medical Education. 2017;17(1):30. 
 
4. 
Dankbaar M, Roozeboom M, Oprins E, Rutten F, Saase J, Van Merrienboer JJG, et al. Gaming as 
a training tool to train cognitive skills in Emergency Care: how effective is it? 2014. p. 13-4. 
 
Currently under review: 
Babar ZUD, Max SA, Martina BG, Rosalia RA, Peek JJ, van Dijk A, Sadeghi H, Mahtab EAF. Virtual 
Reality Simulation as a Training Tool for Perfusionists in Extracorporeal Circulation: Establishing Face and 
Content Validity (2023) 
 Attachments 
☒ Participant information letter and Informed consent document  
☐ Care for data Template – Formulier uitzondering toestemming  
☒ Questionnaires 
☐ Data Management Plan 
☐ Data Transfer Agreement 
☐ Material Transfer Agreement 
☐ Clinical Trial (Site) Agreement 
☐ Other, please describe 
 
 
 
 
 
 
 
 
 

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Appendix 1 
Baseline Participant Data Questionnaire 
1. Gender:_________ 
 
2. Age: ____________   
3. Job title: ________________________________________________________ 
 
4. How many years of work experience do you have? 
• 
<1 year 
• 
1-5 years 
• 
5-10 years 
• 
More than 10 years 
 
5. How many years of experience do you have working with ECMO machines? 
• 
I have never worked with ECMO machines 
• 
0-5 years 
• 
5-10 years 
• 
More than 10 years 
 
6. Do you have experience with gaming consoles (e.g. computer gaming, xbox, playstation)? 
• 
I have never used a gaming console 
• 
I have used a gaming console a few times before  
• 
I am gaming on a regular basis (at least once a month) 
 
7. How often do you use VR hardware/software (e.g. VR gaming, simulations, consoles, 
entertainment etc.)? 
• 
I have never had a VR experience until today 
• 
I have used VR a few times before 
• 
I am experienced and use VR on a regular basis (at least once a month) 
• 
I am an VR expert (have a VR console and applications myself) 
 
8. Do you have experience with physical simulation trainings ()? 
• 
I have never had simulation training before  
• 
I have had simulation trainings multiple times before 
• 
I am a certified simulation trainer 
 
9. Do you have experience with digital training (e.g. e-learning or serious games)? 
• 
I have never had such training before  
• 
I have had a digital training a few times before 
• 
I have had digital trainings multiple times before 
 
10. Do you have experience with simulation training in VR? 
• 
Yes 
• 
No 
Appendix 2 - User Experience USE Questionnaire 

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1. Fully 
disagree 
2. 
Disagree 
3. 
Neutral 
4. 
Agree 
5. 
Fully 
agree 
N/A 
Usefulness 
1 
I learned a lot from this 
simulation about how to 
perform an ECMO 
circuit check 
2 
The training helped me 
being more confident in 
managing ECMO 
patients 
 
 
 
 
 
 
3  
The training helped me 
remember the steps an 
ECMO circuit check 
4 
After the training, I have 
enough knowledge to 
take the lead in an 
ECMO circuit check 
 
 
 
 
 
 
Satisfaction 
6 
I enjoyed participating in 
this ECMO simulation 
7 
I was satisfied with the 
quality of this simulation 
8 
I would recommend 
using this simulation to 
other colleagues 
 
 
 
 
 
 
9 
I would prefer VR 
training additionally to 
conventional training 
(shadowing an expert) 
 
 
 
 
 
 
10 I would prefer VR 
training instead of 
conventional training 
(shadowing an expert) 
Ease of use 

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11 The software is easy to 
use 
12 I learned to use it quickly 
 
 
 
 
 
 
13 The interaction with the 
software felt intuitive 
14 I can use the software 
without written 
instructions 
Immersiveness 
15 I was not distracted 
during the training 
 
 
 
 
 
 
16 The simulator was 
realistic 
17 I felt like I was in a real 
ICU box 
18 I was interested in the 
progress of the events 
within the simulation 
19 I felt actively involved in 
the patient scenario of 
the training 
 
 
 
 
 
 
Please list and rank, in order of importance from most (1) to least (3), the advantages and 
disadvantages of training to use an ECMO machine in VR:  
 
Advantages: 
1. 
 
2.  
 
3. 
 
Disadvantages: 
1. 
 

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2. 
 
3. 
 
Do you have any additional suggestions or recommendations for enhancing or adding new 
features to the simulation? 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
 
Thank you for participating 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 3 
Skill Assessment Form  
 
 
Step 
Completed Correctly 
Yes                    No 
Time to 
action 
(min:s) 
Comments 
1. Checking RPM, flow, and pressures 
2. Checking alarm limits for flow, and 
venous & arterial pressures 
3. Checking for presence of tubing 
clamps 
 
 
 
 
4. Checking for colour difference 
between venous & arterial lines with 
flashlight  
5. Check cannulation site, and confirm 
the canula has not moved 
6. Check lines for blood clots, and 
confirm they are free from kinks or 
obstructions  
7. Check the oxygenator for fibrinogen 
strands or blood clots using the 
flashlight  
8. Check arterial line outflow at the 
oxygenator for clots 
9. Check FiO2 and gas flow settings  
10. Check that the heparin line is 
attached to the oxygenator, and 
confirm the dose on the pump 
 
 
 
 
11. Check that the backup RPM meter 
on the ECMO system is functional, 
and check hand crank is present 
and operational. 
 
 
 
 
12. Check the heater cooler 
temperature settings and check for 
circulation 
 
 
 
 

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13. Check lab results in the patients 
electronic health record 
 
 
 
 
 
 
Additional Comments: