Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-28 @ 6:34 PM
Study NCT ID:
NCT02122367
Status:
UNKNOWN
Last Update Posted:
2014-04-24
First Post:
2014-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-23', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stroke volume variation', 'timeFrame': '5 minutes after volume replacement'}, {'measure': 'pleth variability index', 'timeFrame': '5 minutes after volume replacement'}]}, 'conditionsModule': {'conditions': ['Thyroidectomy', 'Fluid Responsiveness']}, 'descriptionModule': {'briefSummary': 'Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 20\n2. elective robot assisted thyroidectomy\n\nExclusion Criteria:\n\n1. arrhythmia\n2. BMI\\>30\n3. valvular heart disease\n4. pul hypertension\n5. peripheral artery occlusive disease\n6. lung disease\n7. right heart failure'}, 'identificationModule': {'nctId': 'NCT02122367', 'briefTitle': 'Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, 'officialTitle': 'Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy', 'orgStudyIdInfo': {'id': 'Chung-Ang UH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stroke volume variation, pleth variability index', 'description': 'stroke volume variation: recorded using the FloTrac/Vigileo system (Edwards Lifesciences)\n\npleth variability index: recorded using the Masimo Radical-7 monitor (Masimo Corporation, Irvine, CA, USA)', 'interventionNames': ['Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)']}], 'interventions': [{'name': 'HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)', 'type': 'OTHER', 'description': 'HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading', 'armGroupLabels': ['stroke volume variation, pleth variability index']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-755', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seong Deok Kim, MD.PhD', 'role': 'CONTACT', 'email': 'ksddeok@cau.ac.kr', 'phone': '82-2-6299-2571'}, {'name': 'So-young Yang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'So-young Yang, clinical assistant professor', 'role': 'CONTACT', 'email': 'didth79@hanmail.net', 'phone': '82-2-6299-3160'}, {'name': 'Yong-hun Jung, professor', 'role': 'CONTACT', 'email': 'jyh623@cau.ac.kr', 'phone': '82-2-6299-2579'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'So young Yang MD,PhD', 'investigatorFullName': 'So Young Yang', 'investigatorAffiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}}}}