The effect of a dynamic overlay mattress on chest compression quality during cardiopulmonary resuscitation

ISRCTN ISRCTN61041099
DOI https://doi.org/10.1186/ISRCTN61041099
Secondary identifying numbers BPWD1920
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Mr Tim Torsy
Scientific

Schuttershof 20
Nieuwkerken-Waas
9100
Belgium

ORCiD logoORCID ID 0000-0002-2495-1690
Phone +32 495143557
Email tim.torsy@odisee.be

Study information

Study designSingle-blinded, two-arm, parallel-group randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)School
Study typeOther
Participant information sheet ISRCTN61041099_PIS_Dutch_16Sept20.pdf
Scientific titleThe effect of a dynamic overlay mattress on chest compression quality during cardiopulmonary resuscitation: A randomised controlled trial
Study objectivesA 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) studiedChest compression quality in patients who had a cardiac arrest
InterventionIn 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)CPR simulation feedback device
Primary outcome measure1. 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 measures1. 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 study start date01/09/2020
Completion date30/11/2020

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants70
Total final enrolment70
Key inclusion criteria1. 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 criteriaInability to use normal muscle strength in arms and trunk at the time of data collection due to an injury
Date of first enrolment28/09/2020
Date of final enrolment02/10/2020

Locations

Countries of recruitment

  • Belgium

Study participating centres

Odisee University College
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
TI Sint-Carolus
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium

Sponsor information

University College Odisee
University/education

Hospitaalstraat 23
Sint-Niklaas
9100
Belgium

Phone +32 495143557
Email tim.torsy@odisee.be
Website https://www.odisee.be/
ROR logo "ROR" https://ror.org/02c89h825

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/11/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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?
Participant information sheet 16/09/2020 08/10/2020 No Yes
Results article 21/04/2021 08/11/2021 Yes No

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.