Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT06965634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effectiveness of Lung Ultrasonography in Intraoperative Fluid Management
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': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LUS', 'timeFrame': 'peroperative', 'description': 'Lung ultrasound score (LUS) Lung ultrasonography; Lung ultrasound score will be created by performing ultrasonography in 4 quadrants according to the previously defined protocol.\n\n0 points indicated the presence of only A lines, less than 2 B lines\n\n1. point indicated 1-2 B lines\n2. points indicated the presence of more than 3 well-spaced B lines;\n3. points indicated the presence of combined B lines'}], 'secondaryOutcomes': [{'measure': 'PVI', 'timeFrame': 'peroperative', 'description': 'Pulse variable index (PVI) will be measured by finger pulse oximetry with the MASİMO device.'}, {'measure': 'CVP', 'timeFrame': 'peroperative', 'description': 'Central venous pressure(CVP)\n\nPressure values measured by a central venous catheter applied by jugular or subclavian route'}, {'measure': 'postoperative pulmonary complication', 'timeFrame': 'postoperative 6th hour', 'description': 'hypoxia (partial oxygen pressure below 95 on pulse oximetry and 10% decrease from the initial value) atelectasis'}, {'measure': 'biochemical data 1', 'timeFrame': 'postoperative 6th hour', 'description': 'glomerular filtration rate (GFR) values normal results range from 90 to 120 mL/min/1.73 m2.'}, {'measure': 'biochemical data 2', 'timeFrame': 'postoperative 6th hour', 'description': 'Blood urea nitrogen value mg/dl'}, {'measure': 'biochemical data 3', 'timeFrame': 'postoperative 6th hour', 'description': 'Blood creatinine value mmol/dl'}, {'measure': 'Mechanical ventilation data 1', 'timeFrame': 'peroperative', 'description': 'End-Tidal Carbon Dioxide Pressure mm/hg The partial pressure of CO2 detected at the end of exhalation is between 35 and 45 mm Hg or 4.0 to 5.7 kPa.'}, {'measure': 'Mechanical ventilation data 2', 'timeFrame': 'peroperative', 'description': 'Peak inspiratory pressure Values Peak inspiratory pressure is the highest pressure applied to the lungs during inhalation and should be kept below 35 cmH2O.It is automatically measured by respirators.'}, {'measure': 'Mechanical ventilation data 3', 'timeFrame': 'peroperative', 'description': 'Tidal Volume value Tidal volume is the volume of gas moving into and out of the lungs with each breath. Normal tidal volume is 6 to 8 mL/kg, regardless of age. It is automatically measured by respirators.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Fluid Management']}, 'descriptionModule': {'briefSummary': 'Adequate and balanced fluid resuscitation is one of the cornerstones of intraoperative patient management. Over-resuscitation leading to positive fluid balance is associated with increased postoperative mortality and morbidity.\n\nInvasive and non-invasive technologies can be used for the adequacy of intraoperative fluid therapy.\n\nLung ultrasonography (LUS) is a safe and accurate bedside imaging method. LUS, which is frequently used in the diagnosis of postoperative hypoxemia, has also begun to be preferred for fluid management in intensive care units.', 'detailedDescription': 'In this study, we aimed to investigate the effectiveness of intraoperative LUS data in the control of fluid therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who will undergo open surgery in ASA I-III risk classes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with surgery with laparotomy\n\nExclusion Criteria:\n\n* Chronic obstructive pulmonary disease\n* Passed lung operation\n* Uncontrolled hypertension\n* Acute or chronic kidney failure'}, 'identificationModule': {'nctId': 'NCT06965634', 'briefTitle': 'Investigation of the Effectiveness of Lung Ultrasonography in Intraoperative Fluid Management', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Investigation of the Effectiveness of Lung Ultrasonography in the Management of Intraoperative Fluid Therapy, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'BursaYIEAH-2021-6-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lung ultrasound', 'type': 'DEVICE', 'otherNames': ['Lung ultrasound score'], 'description': 'Lung ultrasonography ; lung ultrasonography will be applied in 4 quadrants according to the LUS protocol and LUS score will be created.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Korgün Ökmen, PhD.', 'role': 'CONTACT', 'email': 'korgunokmen@gmail.com', 'phone': '05057081021'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korgün Ökmen', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Korgün Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}