- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646496
Comparison of Chest Compressions Performed With the Lower Limb and the Classical Method (Lower_limb_CPR). (Lower_limb_CPR)
Comparison of the Quality of Chest Compressions Performed With the Lower Limb and the Classical Method During Cardiopulmonary Resuscitation - a Simulation Study.
Chest compressions, alongside early defibrillation, are the most important component of basic life support for adults. High-quality compressions give the patient a chance to survive cardiac arrest.
The chest compression technique, described for years in guidelines, requires kneeling next to the victim and pressing down on the center of the chest with both extended arms at a specific rate and depth. However, there is a lack of scientific data on whether alternative compression methods (for example, using a lower limb) can be considered equally effective in situations where conventional compressions are impossible (e.g., the witness to cardiac arrest is a person with a disability, with an upper limb injury, or an elderly person; or when there is very little space to kneel). The aim of the study is to determine whether compressions performed with the dominant foot by paramedic and nursing students can be considered comparable in quality to conventional compressions. Furthermore, subjective levels of physical fatigue are assessed.
Participants are recruited from among paramedic and nursing students who voluntarily and knowingly consent to participate in the research study.
Inclusion Criteria
- Paramedic and nursing students from the Powiśle Academy of Applied Sciences who voluntarily and knowingly consent to participate in the study.
- Completed first aid training during their studies.
Exclusion Criteria
- Lack of consent to participate in the study.
- Education in another medical profession.
Procedure Students are randomly assigned to the control and study groups. Before participating in the simulation scenario, participants complete a questionnaire asking several demographic questions (age, gender, education, physical activity). Participants then enter the simulation room individually. The activities are not videotaped. From the moment of randomization, students are anonymous to the researcher. Both when completing the questionnaires and recording data from the simulation scenario, participants will be assigned a unique number (generated solely for the study), which prevents identification. Upon entering the simulation room, participants receive all instructions verbally. Students' task in the simulation environment involves performing two minutes of continuous chest compressions. Participants in the control group perform these compressions traditionally, while those in the study group are asked to perform compressions using their dominant leg. Compression quality is assessed using a Prestan Manikin (2000 series) with the CPR FEEDBACK mobile app. Parameters such as compression depth, rate, and relaxation are assessed. Completion of chest compressions on the manikin marks the end of the simulation scenario. Furthermore, participants are verbally questioned after the simulation about their level of physical fatigue on a scale of 1 (none) to 10 (the most severe ever).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pomeranian Voivodeship
-
Kwidzyn, Pomeranian Voivodeship, Poland, 82-500
- Powiślańska Academy of Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Paramedic and nursing students from the Powiśle Academy of Applied Sciences who voluntarily and knowingly consent to participate in the study.
- Completed first aid training during their studies.
Exclusion Criteria
- Lack of consent to participate in the study.
- Education in another medical profession.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Study
|
Verbal instruction to perform chest compressions using the lower limb (foot) before the simulation scenario.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chest compressions quality - Frequency
Time Frame: 2 minutes
|
2 minutes
|
|
Chest compressions quality - Relaxation
Time Frame: 2 minutes
|
2 minutes
|
|
Chest compressions quality - Depth
Time Frame: 2 minutes
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue
Time Frame: 2 minutes
|
Self-assessed physical fatigue (1-10 scale)
|
2 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Powiślańska1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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