Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-01-13 @ 7:37 AM
Study NCT ID:
NCT03062306
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chest Compression and Cerebral Oxygenation During Cardiopulmonary Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The levels of regional brain tissue oxygen saturation (rSO2) providing with chest compressions during Cardiopulmonary Resuscitation (CPR)', 'timeFrame': 'About six month', 'description': 'The data will be obtained by using the Near Infrared Spectroscopy (NIRS) Device and will be recorded rSO2 measurement during the resuscitation of the Cardiac Arrest (CA) patients'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in consciousness on Full Outline of UnResponsiveness (FOUR) Score at one week', 'timeFrame': 'For a week after ROSC', 'description': "The patient's consciousness will be evaluated by FOUR score in patients with ROSC"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Oxygenation', 'Cardiopulmonary Resuscitation', 'Chest Compression'], 'conditions': ['Providing Sufficient Cerebral Oxygenation During CPR']}, 'referencesModule': {'references': [{'pmid': '22322284', 'type': 'BACKGROUND', 'citation': 'Parnia S, Nasir A, Shah C, Patel R, Mani A, Richman P. A feasibility study evaluating the role of cerebral oximetry in predicting return of spontaneous circulation in cardiac arrest. Resuscitation. 2012 Aug;83(8):982-5. doi: 10.1016/j.resuscitation.2012.01.039. Epub 2012 Feb 6.'}, {'pmid': '21958930', 'type': 'BACKGROUND', 'citation': 'Kamarainen A, Sainio M, Olkkola KT, Huhtala H, Tenhunen J, Hoppu S. Quality controlled manual chest compressions and cerebral oxygenation during in-hospital cardiac arrest. Resuscitation. 2012 Jan;83(1):138-42. doi: 10.1016/j.resuscitation.2011.09.011. Epub 2011 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions have critical importance for neurological results and life quality after the return of spontaneous circulation (ROSC).', 'detailedDescription': 'The Near-Infrared Spectroscopy (NIRS), which is used in measuring the cerebral tissue oxygenation is one of the latest technologies that allow the measurement of brain oxygen saturation. With this study, the issue of whether sufficient cerebral oxygenation is provided during CPR applied to patients that have Cardiac Arrest (CA) will be investigated, and the effect of CPR on the patient prognosis after ROSC will be examined. In this study, the aim is to investigate whether sufficient oxygenation is provided in synchronization with chest compressions during CPR; and to test the regional brain tissue saturation with rSO2 measurement, and the prognosis with Full Outline of UnResponsiveness (FOUR) Score in patients with ROSC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing cardiac arrest in intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. All patients undergoing cardiac arrest in intensive care unit\n\nExclusion Criteria:\n\n1. Head injury and intracranial bleeding\n2. Cerebral ischemic vascular event\n3. Pulmonary diseases that may affect blood-oxygen levels\n4. Below the age of 18'}, 'identificationModule': {'nctId': 'NCT03062306', 'acronym': 'CPR', 'briefTitle': 'Chest Compression and Cerebral Oxygenation During Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nevsehir Public Hospital'}, 'officialTitle': 'Can Sufficient Cerebral Oxygenation be Provided in a Synchronized Manner With Chest Compression During Cardiopulmonary Resuscitation?', 'orgStudyIdInfo': {'id': '2016/351'}, 'secondaryIdInfos': [{'id': 'Erciyes University', 'type': 'OTHER', 'domain': 'Clinical Research Ethics Committee'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50100', 'city': 'Nevşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Mehmet Akif YAZAR', 'geoPoint': {'lat': 38.625, 'lon': 34.71222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nevsehir Public Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Critical Care Physician', 'investigatorFullName': 'Mehmet Akif Yazar', 'investigatorAffiliation': 'Nevsehir Public Hospital'}}}}