Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT02771067
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2016-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse pressure variation', 'timeFrame': 'During the surgery. At Day 0.', 'description': 'Ability of pulse pressure variation to predict fluid responsiveness will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy\n\nExclusion Criteria:\n\n* cardiac arrhythmia\n* valvular heart disease\n* ischemic heart disease\n* left ventricular ejection fraction less than 40%\n* Pulmonary disease\n* esophageal disease\n* upper gastrointestinal bleeding\n* Body mass index more than 40 kg/m2.'}, 'identificationModule': {'nctId': 'NCT02771067', 'briefTitle': 'The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2016-0205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulse pressure variation', 'description': 'Pulse pressure variation will be recorded via an arterial catheter after anesthetic induction, before pneumoperitoneum, after pneumoperitoneum, before infusion of 6% hydroxyethyl starch, and after infusion of 6% hydroxyethyl starch. Stroke volume will be also measured to differentiate the fluid responders.', 'interventionNames': ['Procedure: Fluid infusion']}], 'interventions': [{'name': 'Fluid infusion', 'type': 'PROCEDURE', 'description': 'Fluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion.', 'armGroupLabels': ['Pulse pressure variation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}