Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT06254456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluid Responsiveness in Prone Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-07-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse Pressure Variation', 'timeFrame': '1 year', 'description': 'Detect the pulse pressure variation from cardiac output monitoring ( A- line )'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluid responsiveness, prone, EEOT, TVC, ARDS'], 'conditions': ['Fluid Responsiveness']}, 'descriptionModule': {'briefSummary': 'To assess fluid responsiveness in prone patient'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients planed to prone position for treatment\n\nExclusion Criteria:\n\n* no consent\n* arrhythmia\n* pregnancy\n* pre existing pneumothorax\n* pre existing fluid overload\n* cannot insert arterial or central venous catheters'}, 'identificationModule': {'nctId': 'NCT06254456', 'briefTitle': 'Fluid Responsiveness in Prone Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bhumibol Adulyadej Hospital'}, 'officialTitle': 'End Expiratory Occlusion Test and Tidal Volume Challenge Test for Assess Fluid Responsiveness in Prone Patients', 'orgStudyIdInfo': {'id': '95/66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prone patients', 'interventionNames': ['Diagnostic Test: End expiratory occlusion test']}], 'interventions': [{'name': 'End expiratory occlusion test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Tidal volume challenges test'], 'description': 'Fluid responsiveness test', 'armGroupLabels': ['Prone patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bhumibol Adulyadej Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship Training in Critical Care Medicine', 'investigatorFullName': 'Thanadate Sirithanasarn', 'investigatorAffiliation': 'Bhumibol Adulyadej Hospital'}}}}