Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-04 @ 1:42 AM
Study NCT ID:
NCT03938402
Status:
TERMINATED
Last Update Posted:
2021-12-03
First Post:
2019-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different PEEP Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'As a result of COVID-19 pandemics', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2019-04-27', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in intraocular pressure', 'timeFrame': 'Throughout the operation (usually about 1.5 hours).', 'description': 'The physiological value for intraocular pressure is 10-20 mm Hg. Changes in intraocular pressure will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.'}, {'measure': 'Changes in optic nerve sheath diameter', 'timeFrame': 'Throughout the operation (usually about 1.5 hours).', 'description': 'Changes in optic nerve sheath diameter will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraocular pressure', 'Optic nerve sheath diameter', 'Positive end-expiratory pressure'], 'conditions': ['Intraocular Pressure', 'Intracranial Pressure', 'Positive End-expiratory Pressure']}, 'descriptionModule': {'briefSummary': "Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparotomy for gastrointestinal surgery\n* American Society of Anesthesiologists (ASA) 1 or 2 physical status\n* Elective surgery\n\nExclusion Criteria:\n\n* Patients with glaucoma\n* ASA 3 or over physical status\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT03938402', 'briefTitle': 'Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different PEEP Levels', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different Positive End-expiratory Pressure Applications in Laparotomic Surgery', 'orgStudyIdInfo': {'id': '09.2019.378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP 5', 'interventionNames': ['Other: Positive end-expiratory pressure']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP 10', 'interventionNames': ['Other: Positive end-expiratory pressure']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP 15', 'interventionNames': ['Other: Positive end-expiratory pressure']}], 'interventions': [{'name': 'Positive end-expiratory pressure', 'type': 'OTHER', 'description': 'Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.', 'armGroupLabels': ['PEEP 10', 'PEEP 15', 'PEEP 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34899', 'city': 'Istanbul', 'state': 'Pendik', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University School of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ruslan Abdullayev', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University School of Medicine, Dep of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Ruslan Abdullayev', 'investigatorAffiliation': 'Marmara University'}}}}