Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:47 PM
Study NCT ID:
NCT07452367
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Nerve Sheath Diameter and Cognitive Outcomes in Bentall Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between perioperative bilateral ONSD measurements and postoperative cognitive function', 'timeFrame': 'Preoperative baseline to postoperative hospital discharge at 30 days', 'description': 'The Montreal Cognitive Assessment (MoCA) test will be administered preoperatively and after extubation and before hospital discharge to evaluate postoperative cognitive dysfunction (POCD). MoCA assesses multiple cognitive domains including memory, attention, executive function, and abstraction. The relationship between perioperative bilateral optic nerve sheath diameter (ONSD) measurements obtained by ultrasound and the change in MoCA scores will be analyzed to determine whether ONSD can serve as a predictive marker for postoperative cognitive dysfunction in patients undergoing Bentall surgery.This study will evaluate the relationship between changes in optical diameter and postoperative cognitive function. Whether any correlation exists will be assessed based on the study results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bentall surgery', 'Optic nerve sheath diameter', 'Postoperative cognitive dysfunction'], 'conditions': ['Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'Bentall surgery is a major cardiac procedure involving replacement of the ascending aorta, aortic root, and aortic valve, typically requiring cardiopulmonary bypass (CPB) and sometimes deep hypothermic circulatory arrest (DHCA). Due to its complexity, it carries a significant risk of postoperative neurological complications including stroke and postoperative cognitive dysfunction (POCD).\n\nThis prospective observational study aims to evaluate the relationship between perioperative bilateral optic nerve sheath diameter (ONSD) measurements obtained by ultrasound and postoperative cognitive functions in patients undergoing elective Bentall surgery. ONSD is a non-invasive surrogate marker of intracranial pressure that can be measured at the bedside using ultrasound.\n\nIn addition to routine hemodynamic monitoring and cerebral oximetry (NIRS), bilateral ONSD will be measured at predefined intraoperative and postoperative time points. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) test preoperatively and postoperatively, and delirium will be evaluated using the CAM-ICU scale during ICU stay. The association between perioperative ONSD values and postoperative cognitive outcomes, extubation time, ICU stay, and neurological complications will be analyzed.', 'detailedDescription': 'Bentall procedure is a complex cardiac surgery involving replacement of the ascending aorta, aortic root, and aortic valve using a mechanical or bioprosthetic valve conduit and vascular graft. It is commonly performed for aortic aneurysm, aortic dissection, or connective tissue disorders such as Marfan syndrome. The procedure carries a mortality rate of 2-10% and a neurological complication rate of 3-8%, including stroke and postoperative cognitive dysfunction (POCD).Postoperative neurological complications in Bentall surgery are influenced by both patient-related and surgery-related factors. Patient-related risk factors include advanced age (\\>70 years), low educational level, pre-existing cognitive impairment, carotid artery stenosis, and acute type A dissection. Surgery-related risk factors include prolonged CPB and deep hypothermic arrest duration, cerebral perfusion technique, prosthesis type, prolonged mechanical ventilation, postoperative infection, low cardiac output, and anticoagulation compliance.\n\nThe optic nerve sheath (ONS) is a continuation of the intracranial dura mater surrounding the subarachnoid space. It expands in response to elevated intracranial pressure (ICP), particularly in the anterior retrobulbar region. Ultrasound measurement of ONSD is a well-validated, non-invasive bedside method for detecting elevated ICP and has been studied in various clinical settings.\n\nBentall surgeries involving CPB may affect intracranial dynamics through multiple mechanisms including oxygenation fluctuations, electrolyte disturbances, hemodilution, blood transfusion requirements, temperature variations, total circulatory arrest, prolonged surgical duration, and embolic events. Therefore, perioperative monitoring of intracranial status is of particular importance in these patients.\n\nStudy Procedures:\n\nAll patients will have the following baseline data recorded: age, sex, BMI, ASA classification, comorbidities, smoking and alcohol use, medications, ejection fraction (EF), EuroSCORE, and educational level.Preoperative assessments (T0) will include MoCA test, bilateral NIRS-based cerebral oximetry, and bilateral ONSD measurement by ultrasound while breathing room air.\n\nFollowing preoxygenation and routine anesthesia induction, a central venous catheter will be placed. Bilateral NIRS and bilateral ONSD measurements will be performed at the following time points:\n\nT0: Preoperative (room air) T1: 5 minutes after anesthesia induction T2: CPB initiation T3: Maximum hypothermic period T4: Aortic cross-clamp removal T5: CPB termination T6: After sternal closure, before ICU transfer\n\nAt each time point, mean arterial pressure (MAP), arterial blood gas values including hematocrit, PaO2, PaCO2, lactate, and pH will also be recorded.\n\nIntraoperative data to be recorded include: anesthetic agent doses, total opioid and inhalation agent consumption, analgesic technique (fascial plane block or IV analgesia), surgical duration, CPB duration, cross-clamp duration, methylprednisolone dose if used, mannitol amount if used, cerebral perfusion type, TCA duration and temperature if applicable, surgical technique, prosthesis type, degree of hypothermia, vasopressor type and dose, blood transfusion volume, total urine output, and fluid balance.\n\nPostoperative Follow-up:\n\nPatients will be transferred to the cardiovascular surgery ICU and managed by the ICU team according to their standard protocols. The study team will not interfere with clinical management.\n\nPostoperative assessments will include:\n\nBilateral ONSD measurement within the first postoperative hour and after extubation if applicable CAM-ICU delirium assessment twice daily during ICU stay and once daily on the ward RASS sedation score during ICU stay MoCA test after extubation and before hospital discharge VAS pain scores at postoperative 0, 6, 12, and 24 hours\n\nAdditional outcome data to be collected: extubation time, ICU length of stay, hospital length of stay, postoperative complications, need for mechanical circulatory support, reintubation, reoperation, blood transfusion volume, analgesic consumption, and mortality if applicable.\n\nThe observation period begins before anesthesia induction and ends at hospital discharge or mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18-80 years scheduled for elective Bentall procedure at Bursa Yuksek Ihtisas Training and Research Hospital. The study population consists of patients with aortic pathologies including aortic aneurysm, aortic dissection, or connective tissue disorders such as Marfan syndrome, requiring ascending aorta and aortic root replacement with cardiopulmonary bypass (CPB) under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years\n* Scheduled for elective Bentall procedure\n* Requiring cardiopulmonary bypass (CPB)\n* Willing to participate and able to provide informed consent\n* Able to complete the MoCA cognitive assessment test\n\nExclusion Criteria:\n\n* Age below 18 or above 80 years\n* Emergency Bentall surgery\n* Pre-existing diagnosed cognitive impairment or dementia\n* History of prior stroke or neurological disease\n* Significant carotid artery stenosis\n* Inability to complete the MoCA test (language barrier, illiteracy, visual or hearing impairment)\n* Refusal to participate or inability to provide informed consent\n* Patients with known psychiatric disorders\n* Reoperation (redo surgery)\n* Patients with severe renal or hepatic failure'}, 'identificationModule': {'nctId': 'NCT07452367', 'acronym': 'ONCOB', 'briefTitle': 'Optic Nerve Sheath Diameter and Cognitive Outcomes in Bentall Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Relationship Between Bilateral Optic Nerve Sheath Diameter (ONSD) Measurements and Postoperative Cognitive Functions in Bentall Surgeries: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '2025/07-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '16300', 'city': 'Bursa', 'state': 'Yıldırım', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Anıl O Onur, MD', 'role': 'CONTACT', 'email': 'dr.anilonur@gmail.com', 'phone': '05337244608'}, {'name': 'Anıl O Onur, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Burak E Erdolu, Assoc Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bursa High Specialization Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'centralContacts': [{'name': 'Anıl O Onur, MD', 'role': 'CONTACT', 'email': 'dr.anilonur@gmail.com', 'phone': '+905337244608'}], 'overallOfficials': [{'name': 'Anıl O Onur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will not be shared due to patient confidentiality and privacy concerns in accordance with local ethical and legal regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Anesthesiology and Reanimation', 'investigatorFullName': 'Anıl Onur', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}