Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04002193
Status:
COMPLETED
Last Update Posted:
2022-03-24
First Post:
2019-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C074807', 'term': 'BaseLine dental cement'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess influence of the position change on PVI and other variables(PPV, SVV)', 'timeFrame': '1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline)', 'description': 'When position change from supine to modified prone position, to assess the change of PVI and other variables. The correlation of PVI and cardiac output during this change.'}], 'secondaryOutcomes': [{'measure': 'To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position', 'timeFrame': '1. Supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 minute after a position change to prone 3. before and after fluid loading', 'description': 'Record the data of variables after 5 minute hemodynamic stability without changes of drugs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pleth variability index'], 'conditions': ['Fluid Responsiveness', 'Modified Prone Position']}, 'descriptionModule': {'briefSummary': 'To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.', 'detailedDescription': 'Objective :\n\nTo compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.\n\nTo identify Influence of the modified prone position (concord position) on these variables.\n\nMethod\n\n1. To assess influence of the position change on PVI and other variables(PPV, SVV)\n2. To assess PVI to predict fluid responsiveness at modified prone position'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients received cervical operation at modified prone position (concord position)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anaesthesiologists'(ASA) physical status 1-3\n* patients who received cervical operation in modified prone position or knee-chest position\n\nExclusion Criteria:\n\n* Valvular heart disease\n* Congestive heart failure, reduced left ventricular function ( Ejection fraction \\< 40%)\n* Moderate grade of pulmonary disease\n* Arrhythmia (atrial fibrillation, atrial flutter.. etc.)\n* body mass index \\> 30 or \\< 15 kg/m2"}, 'identificationModule': {'nctId': 'NCT04002193', 'briefTitle': 'Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position', 'orgStudyIdInfo': {'id': 'HePark'}}, 'armsInterventionsModule': {'interventions': [{'name': 'volume expansion', 'type': 'OTHER', 'otherNames': ['If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.'], 'description': 'To assess fluid responsiveness'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We did not have the permission of data share from institutional review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical instructor of Anesthesiology and Pain department', 'investigatorFullName': 'Heesun Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}