Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-04 @ 2:54 AM
Study NCT ID:
NCT03004157
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infant Chest Compression
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}], 'ancestors': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systolic blood pressure', 'timeFrame': '1 day', 'description': 'The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)'}], 'secondaryOutcomes': [{'measure': 'diastolic blood pressure', 'timeFrame': '1 day', 'description': 'The blood measurement system was calibrated before each CPR setting and blood pressure including diastolic blood pressure (DBP)'}, {'measure': 'mean arterial pressure', 'timeFrame': '1 day', 'description': 'The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infant', 'cardiopulmonary resuscitation', 'hemodynamics', 'chest compressions'], 'conditions': ['Cardiopulmonary Arrest']}, 'descriptionModule': {'briefSummary': 'Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are below age of two and have poorer chance of survival versus older children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* active paramedics\n* voluntary consent\n\nExclusion Criteria:\n\n* pregnancy\n* back pain\n* wrist pain'}, 'identificationModule': {'nctId': 'NCT03004157', 'briefTitle': 'Infant Chest Compression', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'A Randomized Comparison of Three Chest Compression Techniques and Associated Hemodynamic Effect During Infant CPR: a Randomized Manikin Study', 'orgStudyIdInfo': {'id': 'Infant11/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two finger technique', 'description': 'Two finger technique TFT: the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant CPR by international CPR guidelines', 'interventionNames': ['Procedure: cardiopulmonary resuscitation']}, {'type': 'EXPERIMENTAL', 'label': 'Two thumb technique', 'description': 'Two thumb technique TTHT: the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines', 'interventionNames': ['Procedure: cardiopulmonary resuscitation']}, {'type': 'EXPERIMENTAL', 'label': 'new two-thumb technique', 'description': "new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90 degrees to the chest while closing the fingers of both hands in a fist", 'interventionNames': ['Procedure: cardiopulmonary resuscitation']}], 'interventions': [{'name': 'cardiopulmonary resuscitation', 'type': 'PROCEDURE', 'description': 'CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines', 'armGroupLabels': ['Two finger technique', 'Two thumb technique', 'new two-thumb technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-005', 'city': 'Warsaw', 'state': 'Masovia', 'country': 'Poland', 'facility': 'Medical University of Warsaw, Department of Emergency Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jacek Smereka', 'class': 'UNKNOWN'}, {'name': 'Antonio Rodríguez-Núñez', 'class': 'UNKNOWN'}, {'name': 'Jerzy R Ladny', 'class': 'UNKNOWN'}, {'name': 'Steve Leung', 'class': 'UNKNOWN'}, {'name': 'Kurt Ruetzler', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, DPH, EMT-P', 'investigatorFullName': 'Łukasz Szarpak', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}