- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628693
Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest (Q-CPR)
Quantitative Measurement of Cardiopulmonary Resuscitation During In Hospital Cardiac Arrest
Study Overview
Status
Conditions
Detailed Description
Context: Cardiopulmonary Resuscitation (CPR) guidelines recommend target values for selected CPR parameters related to rate and depth of chest compressions and ventilations, and avoidance of CPR-free intervals. Recent studies on adult patients however show that rescuers often do not adhere to these guidelines. There is currently very little data on the quality of CPR performed on pediatric patients, but given the close similarity in therapy it can be expected that the adherence to Guidelines is suboptimal for this patient group as well. Feedback on quality of chest compressions and ventilations delivered during CPR are most frequently guided by a subjective "code leader", and not objective measurements. Quantitative systems that provide CPR feedback have demonstrated improvement to adult patient treatment. Based on these studies, these feedback systems (termed Quality of CPR or Q-CPR systems) were further improved in a new device called Heartstart MRx with Q-CPR option (MRx/Q-CPR). These devices have been approved by the FDA for use for patients >8 years. The MRX/Q-CPR, attached by a cord to the defibrillator/monitor, detects, displays and records the rate, force and the depth of compressions through an accelerometer and force transducer inside the compression pad. These devices have currently been approved by the CHOP Resuscitation Committee and Medical device committee for clinical implementation in the CHOP Intensive Care units (ICU) and Emergency Department (ED).
Objectives: The goal of this study is to record and analyze the data from the MRx/Q-CPR during in-hospital cardiac arrests of children > 8 years for two research objectives. The primary research objective is to evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR. A secondary research objective is to determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Cardiac Arrest Inclusion Criteria:
- Cardiac arrests occurring in the PICU or ED at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
- Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed
Clinical Staff Inclusion Criteria:
- All clinical staff who participate in resuscitation events in CHOP's ICU or ED
Exclusion Criteria:
- Cardiac arrests for patients classified as "do not attempt resuscitation" (DNAR) 1. CPR chest compressions without the Q-CPR device
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR.
Time Frame: Ongoing
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Ongoing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety.
Time Frame: Ongoing
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Ongoing
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vinay Nadkarni, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
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
- 2006-6-4839
- 1K23HD062629-01A1 (U.S. NIH Grant/Contract)
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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