- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281903
Pediatric Resuscitation With Feedback CPR Devices (PRFD)
November 15, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study
The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation.
Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cardiac arrest is a leading cause of death worldwide.
High-quality chest compressions are of paramount importance for survival and good neurological outcome.
Unfortunately, even health professionals have difficulty performing effective CPR.
Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long.
CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Masovia
-
Warsaw, Masovia, Poland, 03-122
- International Institute of Rescue Research and Education
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)
Exclusion Criteria:
- not meet the above criteria
- wrist or low back diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chest compression of manikins chest
Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.
|
Standard basic life support = chest compressions without any feedback device (manual resuscitation)
feedback devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
Time Frame: 1 month
|
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
effective compressions ratio effective compressions [%] multiplied by flow time [%]
Time Frame: 1 month
|
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
|
1 month
|
|
Flow time sum of all periods during which chest compressions were performed.
Time Frame: 1 month
|
flow time was defined as the sum of all periods during which chest compressions were performed.
|
1 month
|
|
absolute hands-off time sum of all periods without chest compressions or ventilation
Time Frame: 1 month
|
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
|
1 month
|
|
Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
Time Frame: 1 month
|
compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
October 30, 2014
First Submitted That Met QC Criteria
November 3, 2014
First Posted (Estimate)
November 4, 2014
Study Record Updates
Last Update Posted (Estimate)
November 18, 2014
Last Update Submitted That Met QC Criteria
November 15, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPR/2014/05
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.