Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT05264766
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuron-specific enolase', 'timeFrame': '6 hours post cardiopulmonary bypass off', 'description': 'Neuronal injury marker. The higher the value, the worse the outcome'}, {'measure': 'Confusion Assessment Method - Intensive Care Unit (CAM-ICU)', 'timeFrame': 'Changes of CAM-ICU from 12 hours to 24 hours postoperative', 'description': 'Tools to assess delirium. The higher the errors, the worse the outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cooling helmet', 'neuron specific enolase', 'delirium', 'open heart surgery'], 'conditions': ['Heart; Surgery, Heart, Functional Disturbance as Result']}, 'descriptionModule': {'briefSummary': 'To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery', 'detailedDescription': 'Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing their first open heart surgery using cardiopulmonary bypass\n* Age ≥18 year-old\n* Patient with American Society of Anesthesiologists (ASA) III\n* Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented\n* Patient fluent in Indonesia\n\nExclusion Criteria:\n\n* Patients did not give consent to participate in the study\n* Patients with central nervous system disease (stroke, intracranial tumor)\n* Patients with psychiatric problem (schizophrenia, depression)\n* Patients with cognitive problem\n* Blind and deaf patient\n* Patient on psychotrophic or narcotics medication\n\nDrop out criteria\n\n* Surgery without cardiopulmonary bypass\n* Patient demise after surgery\n* Patients decided to refrain from the study'}, 'identificationModule': {'nctId': 'NCT05264766', 'briefTitle': 'The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cooling helmet on', 'description': 'Cooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on', 'interventionNames': ['Device: Cooling helmet on']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cooling helmet off', 'description': 'Cooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on', 'interventionNames': ['Device: Cooling helmet off']}], 'interventions': [{'name': 'Cooling helmet on', 'type': 'DEVICE', 'description': 'Cooling helmet with circulating cold water', 'armGroupLabels': ['Cooling helmet on']}, {'name': 'Cooling helmet off', 'type': 'DEVICE', 'description': 'Cooling helmet without circulating cold water', 'armGroupLabels': ['Cooling helmet off']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Central National Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamad Prakoso Adji', 'investigatorAffiliation': 'Indonesia University'}}}}