Condition category
Circulatory System
Date applied
15/09/2020
Date assigned
17/09/2020
Last edited
08/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

https://www.odisee.be/

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

Editorial Notes

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.