Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-05 @ 10:50 AM
Study NCT ID:
NCT04850092
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic arterial elastance before positional change', 'timeFrame': '1 minute before positional change', 'description': 'Dynamic arterial elastance, defined as the ratio of pulse pressure variance/stroke volume variance will be recorded 1 minute before positional change'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': 'During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are scheduled for spine surgery and need positional change from supine to prone positioin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia\n\nExclusion Criteria:\n\n* arrythmia\n* pulmonary disease\n* increased intracranial pressure\n* decreased cardiac function (ejection fraction \\< 50%)\n* obesity (body mass index \\> 40)'}, 'identificationModule': {'nctId': 'NCT04850092', 'briefTitle': 'Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Investigation on Dynamic Arterial Elastance as a Predictor of Hypotension Caused by the Positional Change From Supine to Prone (SuProne Study).', 'orgStudyIdInfo': {'id': 'KBSMC 2021-04-038'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-hypotensive', 'description': 'Mean blood pressure is maintained after positional change from supine to prone.', 'interventionNames': ['Other: Positional change from supine to prone']}, {'label': 'Hypotensive', 'description': 'Mean blood pressure decrease \\< 20% after positional change from supine to prone.', 'interventionNames': ['Other: Positional change from supine to prone']}], 'interventions': [{'name': 'Positional change from supine to prone', 'type': 'OTHER', 'description': 'Patient is turned from supine to prone position for spine surgery', 'armGroupLabels': ['Hypotensive', 'Non-hypotensive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eunah Cho, MD', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}