Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-27 @ 7:35 PM
Study NCT ID:
NCT01402934
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2011-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Pressure Variation in Spontaneously Breathing Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C485123', 'term': 'HES 130-0.4'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2011-05-29', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pulse pressure variation', 'timeFrame': 'three respiratory cycles, an expected average of 30 seconds'}], 'secondaryOutcomes': [{'measure': 'hemodynamic parameters', 'timeFrame': 'before and after fluid loading, 1 mimute', 'description': 'systolic blood pressure (SBP), dyastolic BP, mean BP, heart rate, cardiac index, stroke volume varation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulse Pressure Variation', 'Spontaneously Breathing']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.', 'detailedDescription': 'Pulse pressure variation (PPV) is known to be a dynamic indicator to predict fluid responsiveness in mechanically ventilating patients. PPV is generated by cardiopulmonary interaction with respiratory cycles. In spontaneous breathing, the cardiopulmonary interaction may lead to PPV by inverted manner. In this study, the investigators will evaluate the ability of PPV to predict fluid responsiveness in spontaneously breathing patients. Before induction of anesthesia, radial artery cannulation is performed, and FloTrac/Vigileo (Edwards Lifesciences Corp., Irvine, USA) system is connected. And then, the investigators will measure baseline data including invasive blood pressure, pulse pressure, cardiac index, stroke volume variation in two different conditions: during tidal spontaneous breathing and during forced spontaneous breathing. All hemodynamic measurement will be repeated after infusion of fluid using 6mL/kg of hydroxyethyl starch solution (Voluven), and will be averaged over 3 minutes. Patients whose cardiac index increased by \\>15% to fluid infusion is defined as responders. The investigators will compare the hemodynamic parameters between responders and non-responders. To evaluate the ability to predict volume responsiveness, receiver operating characteristics curves of the PPV will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing thoracic surgery\n\nExclusion Criteria:\n\n* preoperative arrhythmia\n* left ventricular ejection fraction \\<40%\n* intra-cardiac valve disease\n* intra-cardiac shunt\n* pulmonary artery hypertension\n* severe peripheral vascular obstructive disease\n* decreased pulmonary function'}, 'identificationModule': {'nctId': 'NCT01402934', 'briefTitle': 'Pulse Pressure Variation in Spontaneously Breathing Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery', 'orgStudyIdInfo': {'id': 'JHBahk_PPV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fluid infusion', 'interventionNames': ['Procedure: Hydroxyethyl starch solution (Voluven) infusion']}], 'interventions': [{'name': 'Hydroxyethyl starch solution (Voluven) infusion', 'type': 'PROCEDURE', 'description': 'fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg', 'armGroupLabels': ['fluid infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae-Hyon Bahk', 'oldOrganization': 'Seoul National University Hospital'}}}}