Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 10:09 AM
Study NCT ID:
NCT06423833
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The validity of Trendelenburg maneuver', 'timeFrame': 'At the end of Trendelenburg maneuver within 1 minute', 'description': 'Measurement of the validity of Trendelenburg maneuver to predict fluid responsiveness by measuring the percentage change in velocity time integral (VTI) by Doppler echocardiography in high risk-surgical patients.'}], 'secondaryOutcomes': [{'measure': 'Correlation between the accuracy of the percentage change in velocity time integral (VTI) during Trendelenburg maneuver and passive leg raising test (PLR) test', 'timeFrame': 'At the end of Trendelenburg maneuver and passive leg raising test within 1 minute', 'description': 'Correlation between the accuracy of the percentage change in velocity time integral (VTI)during Trendelenburg maneuver and passive leg raising test will be measured.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trendelenburg Maneuver', 'Passive Leg Raising', 'High-Risk Surgical Patients']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether Trendelenburg maneuver can be used to predict fluid responsiveness in high-risk surgical patients in intensive care unit as compared to Passive Leg Raising test.', 'detailedDescription': "Passive Leg Raising test is a well validated dynamic method to predict fluid responsiveness with many advantages as it doesn't use fluid loading, its effect is reversible, and it doesn't rely on heart-lung interaction. However, it has many limitations as (has false negative effect in patients with intra-abdominal hypertension), also, it may not be suitable in some surgical patients.\n\nTrendelenburg maneuver (TM) is often used to treat hemodynamic unstable patients when hypovolemia is suspected, through a mechanism similar to Passive Leg Raising test Yonis, et al reports that change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in prone position under protective ventilation. Another study reports that change in velocity time integral during trendelenburg maneuver predicts fluid responsiveness in cardiac surgical patients in operating rooms"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old.\n* Criteria of high-risk surgical patients:\n\n 1. Elderly ≥ 70 years old undergoing major surgery.\n 2. Physical status ≥ 3 or more undergoing major surgery.\n 3. Major intraoperative hemorrhage with Surgical Apgar Score (SAS 0-4).\n 4. Emergency of upper abdominal surgery.\n* Criteria of hypoperfusion ≥ 2 or more the following:\n\n 1. Mean arterial blood pressure \\< 65 mmHg.\n 2. Urine output \\< 0.5 ml/Kg/hr.\n 3. Capillary refilling time \\> 4 seconds.\n 4. Blood lactate \\> 2 mmol/L.\n 5. ScvO2 \\< 70%.\n 6. CO2 gap \\> 6 mmHg.\n* Provided that:SpO2 ≥ 90% and Hb ≥ 7 g/dl.\n\nExclusion Criteria:\n\n* Patients with body mass index \\> 35 kg/m2.\n* Pregnant female.\n* Contraindications to the Trendelenburg position or PLR test (major head trauma, intra-abdominal hypertension and gastric retention).\n* Poor echo window or unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable velocity time integral measurements at the left ventricular outflow tract \\[LVOT\\]).'}, 'identificationModule': {'nctId': 'NCT06423833', 'briefTitle': 'Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients', 'orgStudyIdInfo': {'id': '36264MD32/2/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trendelenburg maneuver', 'description': 'The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Trendelenburg maneuver (TM) in high-risk surgical patients by trans-thoracic Doppler echo cardiography', 'interventionNames': ['Diagnostic Test: Trendelenburg maneuver (TM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Passive leg raising test', 'description': 'The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during passive leg raising (PLR) test in high-risk surgical patients by trans-thoracic Doppler echo cardiography', 'interventionNames': ['Diagnostic Test: Passive leg raising test']}], 'interventions': [{'name': 'Trendelenburg maneuver (TM)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Trendelenburg maneuver (TM) in high-risk surgical patients by trans-thoracic Doppler echo cardiography.', 'armGroupLabels': ['Trendelenburg maneuver']}, {'name': 'Passive leg raising test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Passive leg raising (PLR) test in high-risk surgical patients by trans-thoracic Doppler echo cardiography.', 'armGroupLabels': ['Passive leg raising test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt', 'investigatorFullName': 'Fatma Mohamed Samy Elaiashy', 'investigatorAffiliation': 'Tanta University'}}}}