Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000658415
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
20/06/2025
Date last updated
22/06/2025
Date data sharing statement initially provided
20/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of body position modifications during simulated CPR on chest compression quality in patients with obesity.
Scientific title
Effect of body position modifications on chest compression depth, rate and recoil during simulated cardiopulmonary resuscitation (CPR) in patients with obesity
Secondary ID [1] 314355 0
Nil known
Universal Trial Number (UTN)
U1111-1322-2362
Trial acronym
RESCUE-OB (RESuscitation Chest compression Upgrade Evaluation in patients with OBesity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 337723 0
Cardiac arrest 337342 0
Condition category
Condition code
Emergency medicine 333728 333728 0 0
Resuscitation
Cardiovascular 333729 333729 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 60 paramedics will be included in this study. All participants will perform 2-minute chest compression (CPR) sessions on manikins simulating patients with and without obesity. Interventions involve modified body positioning to optimise compression mechanics. Each paramedic will perform compressions in both standard and modified positions in a randomized crossover design. CPR quality parameters (compression depth, rate, and full chest recoil) are measured using the Laerdal QCPR Meter 2.

1. Paramedics will perform CPR in the following three randomized conditions:
- Standard CPR on a manikin with normal body mass, placed on the floor
- CPR on an obese manikin placed on the floor
- CPR on an obese manikin placed on the floor, using a 10 cm knee pad to assist ergonomic positioning

All compressions are performed without real-time feedback. A 3-minute rest is provided between sessions. Each participant will also complete a pre-test demographic questionnaire (age, sex, BMI, profession, CPR experience, etc.). All procedures are conducted at the Medical Simulation Centre and EMS training facilities under standardised supervision.
Intervention code [1] 330971 0
Treatment: Other
Comparator / control treatment
Standard body position for CPR as recommended by European Resuscitation Council guidelines, without any positioning modifications.
Control group
Active

Outcomes
Primary outcome [1] 341715 0
Full chest recoil
Timepoint [1] 341715 0
Immediately after each 2-minute CPR session in each test condition
Primary outcome [2] 341714 0
Compression rate
Timepoint [2] 341714 0
Immediately after each 2-minute CPR session in each test condition
Primary outcome [3] 341320 0
Compression depth (mm), measured using Laerdal QCPR Meter 2
Timepoint [3] 341320 0
During each 2-minute CPR session in each trial condition (baseline and modified positions)
Secondary outcome [1] 447113 0
Participant-reported perceived exertion following CPR session
Timepoint [1] 447113 0
Immediately after each CPR session

Eligibility
Key inclusion criteria
1. Currently working as a paramedic in EMS system.
2. At least 1 year of professional experience
3. No medical contraindications to performing CPR
4. Voluntary written informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe or acute cardiovascular, respiratory, or musculoskeletal disorders
2. Any health conditions that may impair safe or effective performance of chest compressions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The order of intervention conditions was concealed using sealed opaque envelopes containing random sequences prepared by a researcher not involved in data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The crossover sequence (order of positions tested) was generated using simple randomisation via a random number generator in Excel by an independent researcher.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study (n = 60) was determined based on pilot data and an expected medium effect size. All participants will be paramedics. All statistical analyses (e.g. paired t-tests, ANOVA, regression models) will be conducted within this group. Subgroup analyses will additionally explore associations with participant characteristics (e.g. age, sex, BMI, years of CPR experience). All analyses will be performed using SPSS and Statistica.

Sample size calculation was based on published data from Secombe et al. and focused on key CPR quality parameters: compression adequacy, rate, and depth. For compression adequacy, the estimated effect size was 0.6459, with power (1-ß) = 0.80 and a = 0.05, resulting in a minimum of 31 participants. For compression rate, a medium effect size of 0.5004 required at least 52 participants. The analysis was conducted using G*Power software. To ensure statistical power across all primary outcomes, the final planned sample size is 60 paramedics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
29/12/2028
Actual
Date of last data collection
Anticipated
29/12/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 27132 0
Poland
State/province [1] 27132 0

Funding & Sponsors
Funding source category [1] 318875 0
University
Name [1] 318875 0
Wroclaw Medical University
Country [1] 318875 0
Poland
Primary sponsor type
University
Name
Wroclaw Medical University
Address
Country
Poland
Secondary sponsor category [1] 321337 0
None
Name [1] 321337 0
Address [1] 321337 0
Country [1] 321337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317488 0
Komisja Bioetyczna przy Uniwersytecie Medycznym we Wroclawiu
Ethics committee address [1] 317488 0
Ethics committee country [1] 317488 0
Poland
Date submitted for ethics approval [1] 317488 0
02/01/2025
Approval date [1] 317488 0
16/01/2025
Ethics approval number [1] 317488 0
KB 12/2025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141214 0
Mr Aleksander Mickiewicz
Address 141214 0
Department of Emergency Medical Service, Faculty of Nursing and Midwifery, Wroclaw Medical University, Parkowa 34, 51-616 Wroclaw, Poland,
Country 141214 0
Poland
Phone 141214 0
+48 71 346 82 75
Fax 141214 0
Email 141214 0
[email protected]
Contact person for public queries
Name 141215 0
Aleksander Mickiewicz
Address 141215 0
Department of Emergency Medical Service, Faculty of Nursing and Midwifery, Wroclaw Medical University, Parkowa 34, 51-616 Wroclaw, Poland,
Country 141215 0
Poland
Phone 141215 0
+48 71 346 82 75
Fax 141215 0
Email 141215 0
[email protected]
Contact person for scientific queries
Name 141216 0
Aleksander Mickiewicz
Address 141216 0
Department of Emergency Medical Service, Faculty of Nursing and Midwifery, Wroclaw Medical University, Parkowa 34, 51-616 Wroclaw, Poland,
Country 141216 0
Poland
Phone 141216 0
+48 71 346 82 75
Fax 141216 0
Email 141216 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.