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Pediatric Resuscitation With Feedback CPR Devices (PRFD)

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ClinicalTrials.gov Identifier: NCT02281903
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: The TrueCPR feedback device Device: Standard BLS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Chest compression of manikins chest
Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.
Device: The TrueCPR feedback device
feedback devices

Device: Standard BLS
Standard basic life support = chest compressions without any feedback device (manual resuscitation)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 [%]

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281903


Locations
Poland
International Institute of Rescue Research and Education
Warsaw, Masovia, Poland, 03-122
Sponsors and Collaborators
International Institute of Rescue Research and Education
Investigators
Principal Investigator: Lukasz Szarpak Institute of Cardiology

Responsible Party: Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02281903     History of Changes
Other Study ID Numbers: CPR/2014/05
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases