Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 2:49 AM
Study NCT ID:
NCT04060069
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-15', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum', 'timeFrame': 'up to 10 months', 'description': 'to evaluate reliability of stroke volume variation in evaluating the response to fluid administration'}, {'measure': 'to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum', 'timeFrame': 'up to 10 months', 'description': 'to evaluate reliability of pulse pressure variation in evaluating the response to fluid administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluid Responsiveness']}, 'descriptionModule': {'briefSummary': 'The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.', 'detailedDescription': 'After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45 patients over the age of 18 who would undergo elective laparoscopic gynecological surgery and had the ASA (American Society of Anesthesiologists) risk classification I-II were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years old patients\n* Will undergo elective laparoscopic gynecological surgery\n* ASA I-II\n\nExclusion Criteria:\n\n* Obese patients (body mass index\\> 30 kg.m2)\n* Patients who had arrhythmia\n* Patients who had cardiac insufficiency.'}, 'identificationModule': {'nctId': 'NCT04060069', 'briefTitle': 'Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery', 'orgStudyIdInfo': {'id': 'KOU GOKAEK 2016/272'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before pneumoperitoneum', 'description': 'Fluid administration', 'interventionNames': ['Other: Ringer Lactate']}], 'interventions': [{'name': 'Ringer Lactate', 'type': 'OTHER', 'description': 'Fluids', 'armGroupLabels': ['Before pneumoperitoneum']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Tulay Sahin', 'investigatorAffiliation': 'Kocaeli University'}}}}