Plain English Summary
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-minutes 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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Tim Torsy
ORCID ID
https://orcid.org/0000-0002-2495-1690
Contact details
Schuttershof 20
Nieuwkerken-Waas
9100
Belgium
+32 495143557
tim.torsy@odisee.be
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
BPWD1920
Study information
Scientific title
The effect of a dynamic overlay mattress on chest compression quality during cardiopulmonary resuscitation: A randomised controlled trial
Acronym
Study hypothesis
A dynamic overlay mattress has a negative impact on chest compression quality during CPR
Ethics approval
Following external advice, the approval of the study by a medical ethics review committee was waived as this is manikin-based simulation research.
Study design
Single-blinded, two-arm, parallel-group randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Other
Patient information sheet
See additional files
Condition
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 names
CPR simulation feedback device
Primary outcome measure
1. Chest compression rate is measured in the total number of compressions per min using a feedback device
2. Sternum-to-spine chest compression depth is measured in mm using a feedback device
3. Hand positioning is measured in scores out of 100 using a feedback device
Secondary outcome measures
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
Overall trial start date
01/09/2020
Overall trial end date
30/11/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
Inability to use normal muscle strength in arms and trunk at the time of data collection due to an injury
Recruitment start date
28/09/2020
Recruitment end date
02/10/2020
Locations
Countries of recruitment
Belgium
Trial participating centre
Odisee University College
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
Trial participating centre
TI Sint-Carolus
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
Sponsor information
Organisation
University College Odisee
Sponsor details
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
+32 495143557
tim.torsy@odisee.be
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
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.
Intention to publish date
30/11/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN61041099_PIS_Dutch_16Sept20.pdf Uploaded 08/10/2020