Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT04152135
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2019-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Changes With Passive Leg Raising Maneuver in Patients Undergoing Arthroscopic Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-02', 'studyFirstSubmitDate': '2019-11-02', 'studyFirstSubmitQcDate': '2019-11-02', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'passive leg raising maneuver', 'timeFrame': '2 minutes', 'description': 'Head of bed at 0 degrees flat and both legs elevated to 45 degrees'}, {'measure': 'vena cava inferior diameter', 'timeFrame': '2 minutes', 'description': 'Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '2 minutes', 'description': 'non-invasive measurement, routine monitoring'}, {'measure': 'Heart rate', 'timeFrame': '2 minutes', 'description': 'Routine monitoring'}, {'measure': 'End-tidal CO2', 'timeFrame': '2 minutes', 'description': 'Routine monitoring after intubation'}, {'measure': 'plethysmographic waveform', 'timeFrame': '2 minutes', 'description': 'Routine monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['passive leg raising maneuver, vena cava inferior diameter'], 'conditions': ['Arthroscopic Shoulder Surgery']}, 'descriptionModule': {'briefSummary': 'After intubation of the patients who are undergoing arthroscopic shoulder surgery, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and inferior vena cava (IVC) diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.', 'detailedDescription': 'Patients aged between 18-65 years who are undergoing arthroscopic shoulder surgery will be examined. After giving detailed information, voluntary certificate will be taken from patients who accept to participate in the study. Heart rate, oxygen saturation and blood pressure values will be recorded by routine monitoring. After intubation of the patients, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and IVC diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ASA 1-2 status patients between the ages of 18-65 to be performed arthroscopic shoulder surgery with informed consent', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old patients,\n* The American Society of Anesthesiologists (ASA) physical status classification score 1-2,\n* Patients scheduled for arthroscopic shoulder surgery, intubated, sitting position\n\nExclusion Criteria:\n\n* Patient refusal,\n* Patients with current heart and valve disease,\n* Patients with ASA 3-4 status,\n* Emergency cases'}, 'identificationModule': {'nctId': 'NCT04152135', 'briefTitle': 'Hemodynamic Changes With Passive Leg Raising Maneuver in Patients Undergoing Arthroscopic Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Evaluation of Volume Status by Passive Leg Removal Maneuver and Vena Cava Inferior Diameter Measurements Before the Position of Patients in Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vena cava inferior diameter measurement', 'type': 'PROCEDURE', 'description': 'Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research assistant', 'investigatorFullName': 'merve namlı emlek', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}