The effect of a dynamic overlay mattress on chest compression quality during cardiopulmonary resuscitation
| ISRCTN | ISRCTN61041099 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61041099 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | BPWD1920 |
| Sponsor | University College Odisee |
| Funder | Investigator initiated and funded |
- Submission date
- 15/09/2020
- Registration date
- 17/09/2020
- Last edited
- 08/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Adult cardiac arrest both in- and out-of-hospital is common and associated with high mortality and morbidity. High-quality cardiopulmonary resuscitation (CPR) is important for patient survival and for a decent neurological outcome after a cardiac arrest. Therefore, It is important to identify factors that can affect CPR quality.
This study investigates the effect of a dynamic mattress overlay on the quality of cardiac massage during resuscitation as the certainty of the available evidence is still very low.
Who can participate?
Students enrolled in one of the nursing education programs (offered by the participating centres) who have completed basic CPR training and their first year of nursing education.
What does the study involve?
Students have to complete a 2-minute cardiac arrest CPR scenario on a manikin. For a random sample of half of the students, the manikin will be on a bed with a memory foam mattress alone, and for the other half, the manikin will be on a bed with a memory foam mattress and dynamic overlay mattress combination.
What are the possible benefits and risks of participating?
Participation in this study offers a chance to participate in the development of evidence-based nursing. No risks are anticipated.
Where is the study run from?
Odisee University College and TI Sint-Carolus (Belgium)
When is the study starting and how long is it expected to run for?
From September 2020 to November 2020
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Tim Torsy
tim.torsy@odisee.be
Contact information
Scientific
Schuttershof 20
Nieuwkerken-Waas
9100
Belgium
 ORCID ID |
0000-0002-2495-1690 |
|---|---|
| Phone | +32 495143557 |
| tim.torsy@odisee.be |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded, two-arm, parallel-group randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN61041099_PIS_Dutch_16Sept20.pdf |
| Scientific title | The effect of a dynamic overlay mattress on chest compression quality during cardiopulmonary resuscitation: A randomised controlled trial |
| Study objectives | A dynamic overlay mattress has a negative impact on chest compression quality during CPR |
| Ethics approval(s) | Following external advice, the approval of the study by a medical ethics review committee was waived as this is manikin-based simulation research. |
| Health condition(s) or problem(s) studied | Chest compression quality in patients who had a cardiac arrest |
| Intervention | In this manikin-based simulation study, participants (students from two nursing education programs) are going to be allocated to one arm of the two-arm parallel-group design using block randomisation. The students will be blinded to the allocation. Student body height (in cm), body weight (in kg) will be collected. The students will be assessed for the quality of chest compressions during adult cardiopulmonary resuscitation (CPR), in a 2-minutes cardiac arrest CPR scenario, on either: 1. A manikin in bed on a memory foam mattress (control group) 2. A manikin in bed on a dynamic overlay mattress on top of a memory foam mattress (intervention group) |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CPR simulation feedback device |
| Primary outcome measure(s) |
1. Chest compression rate is measured in the total number of compressions per min using a feedback device |
| Key secondary outcome measure(s) |
1. The predictive effect of body height (cm), body weight (kg), hand positioning (scores out of 100), and mattress type (dynamic overlay mattress or not) on depth and frequency of chest compressions measured using a feedback device |
| Completion date | 30/11/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. Enrolled as a student in one of the two selected nursing education programs 2. Aged ≥18 years 3. Successfully completed a basic CPR training 4. Successfully completed first year of nursing education |
| Key exclusion criteria | Inability to use normal muscle strength in arms and trunk at the time of data collection due to an injury |
| Date of first enrolment | 28/09/2020 |
| Date of final enrolment | 02/10/2020 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Sint-Niklaas
9100
Belgium
Sint-Niklaas
9100
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available as an SPSS dataset at any time upon request from the researchers (Tim Torsy - tim.torsy@odisee.be). Datasets are anonymized, are not intended for IPD sharing and wil only made available based on a good, well-founded motivation. Datasets will only be made available until the next major update of the ERC guidelines for adult basic life support and automated external defibrillation. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/04/2021 | 08/11/2021 | Yes | No | |
| Participant information sheet | 16/09/2020 | 08/10/2020 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN61041099_PIS_Dutch_16Sept20.pdf
- Uploaded 08/10/2020
Editorial Notes
08/11/2021: Publication reference and total final enrolment added.
08/10/2020: The participant information sheet has been uploaded.
06/10/2020: The following changes have been made:
1. The recruitment start date has been changed from 19/10/2020 to 28/09/2020.
2. The recruitment end date has been changed from 23/10/2020 to 02/10/2020.
17/09/2020: Trial’s existence confirmed by Odisee University College.
