Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-08 @ 7:22 AM
Study NCT ID:
NCT00628693
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR.', 'timeFrame': 'Ongoing'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Ongoing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CPR'], 'conditions': ['Cardiac Arrest', 'Cardiopulmonary Resuscitation']}, 'descriptionModule': {'briefSummary': 'The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations delivered during cardiac arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings utilizing the MRx/Q-CPR. The data collected will be analyzed for several purposes - for comparison with current American Heart Association (AHA) Cardiopulmonary Resuscitation (CPR) guidelines and to determine chest wall stiffness for CPR modeling efforts and construction of biofidelic manikins or test dummies for CPR and auto safety.', 'detailedDescription': '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).\n\nObjectives: 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Cardiac arrests occurring in the Pediatric Intensive Care Unit or Emergency Department at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCardiac Arrest Inclusion Criteria:\n\n* Cardiac arrests occurring in the PICU or ED at The Children\'s Hospital of Philadelphia equipped with the MRx/Q-CPR\n* Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed\n\nClinical Staff Inclusion Criteria:\n\n\\- All clinical staff who participate in resuscitation events in CHOP\'s ICU or ED\n\nExclusion Criteria:\n\n* Cardiac arrests for patients classified as "do not attempt resuscitation" (DNAR) 1. CPR chest compressions without the Q-CPR device'}, 'identificationModule': {'nctId': 'NCT00628693', 'acronym': 'Q-CPR', 'briefTitle': 'Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Quantitative Measurement of Cardiopulmonary Resuscitation During In Hospital Cardiac Arrest', 'orgStudyIdInfo': {'id': '2006-6-4839'}, 'secondaryIdInfos': [{'id': '1K23HD062629-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23HD062629-01A1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Vinay Nadkarni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}