Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT06255132
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between neurological pupil index (NPi) and Post-operative delirium', 'timeFrame': 'Intraoperative (day 0)', 'description': 'We want to relate pupillary reactivity, assessed with automated pupillometry such as the Neurological pupil index (numerical value:0-5) during surgery, with Postoperative delirium (assessed with CAM-ICU score during the first 5 postoperative days).'}], 'secondaryOutcomes': [{'measure': 'Correlation between early prediction model for delirium (E-PRE-DELIRIC) and POD', 'timeFrame': 'E-PREDELIRIC is calculated at ICU admission ( day 0)', 'description': 'E-PREDELIRIC is a standard prediction model for ICU delirium (%) and is calculated at ICU admission. We aim to evaluate the correlation between the model and Postoperative delirium in cardiovascular patients'}, {'measure': 'Correlation between regional cerebral saturation (rSO2) and POD occurrence', 'timeFrame': 'rSO2 is monitored during surgery (Day 0)', 'description': 'Regional cerebral saturation (rSO2) ranges between 0 and 100% and is a standard of care during open heart surgery. We want to evaluate the correlation between intraoperative cerebral saturation during surgery and POD.'}, {'measure': 'Correlation between Cardiopulmonary bypass duration and POD.', 'timeFrame': 'Intraoperative', 'description': 'Cardiopulmonary bypass duration within heart surgery is variable (min), depending on different surgical factors. We aim to evaluate if the duration of CPB could be related to POD occurrence'}, {'measure': 'Multivariate model for POD prediction.', 'timeFrame': 'Day 0', 'description': 'a multivariate analysis will be performed to build a prediction model for postoperative delirium in the specific population of cardiovascular patients who underwent open heart surgery.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['automated pupillometry', 'cardiac surgical procedures'], 'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery.\n\nThe goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.', 'detailedDescription': "Consent was obtained during the hospitalization before the planned surgery.\n\nOn the day of surgery, before general anesthesia is started, Near-infrared spectroscopy (NIRS) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. Pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, NPi) are also recorded from both the right and left eye with AP (NPi-200).\n\nFrom the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant NIRS values (at least one measurement per eye per operative phase). Moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured.\n\nFollowing surgery, the patient is transferred to the Cardiac Intensive Care Unit. There, NIRS monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as RASS sedation scale \\>-3).\n\nOnce the patient has regained consciousness (RASS\\>-3), is assessed twice a day (morning and afternoon) with the Confusion assessment method-intensive care unit (CAM-ICU) score by the nursing staff and/or medical staff. The presence or absence of POD will then be reported as well as any pharmacological and non-pharmacological treatments.\n\nAny neurological complications and diagnostic investigations arising in the post-operative period will also be noted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing elective open cardiac surgery (\\>18 yr)\n* Elective open cardiac surgery and cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Patients \\<18 years of age\n* Emergency surgeries\n* Heart operations, not including extracorporeal circulation\n* Surgery for aortic arch dissection with hypothermia and/or circulatory arrest\n* Patients affected by psychiatric disorders undergoing with or without neuroleptic therapy\n* Patients who have the refused consent\n* Patients with ocular problems (acute or previous trauma to one or both eyes, blindness, ocular prosthesis)'}, 'identificationModule': {'nctId': 'NCT06255132', 'briefTitle': 'Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'Exploratory Study on the Role of Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium', 'orgStudyIdInfo': {'id': '4079CESC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients undergoing open heart surgery', 'interventionNames': ['Device: Automated pupillometer NPi-200']}], 'interventions': [{'name': 'Automated pupillometer NPi-200', 'type': 'DEVICE', 'description': 'Pupillary variables in both eyes are recorded and measured with NPi-200 every 30 minutes from the induction of anesthesia. At the end of the surgery, the patient is transferred to the intensive care unit (ICU), and the pupillary variables are recorded until the patient regains consciousness (Richmond agitation sedation scale, RASS\\>-3). Specific hemodynamic, respiratory, surgical, and EBP data are also recorded as well as NIRS variables.\n\nAs soon as the patient had regained consciousness (RASS \\> 3), they were assessed for delirium for a total period of five days. Nursing and/or medical staff administered the CAM-ICU score to patients twice a day (morning and afternoon).', 'armGroupLabels': ['Patients undergoing open heart surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37126', 'city': 'Verona', 'state': 'Vr', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Romagnosi, MD', 'role': 'CONTACT', 'email': 'federico.romagnosi@aovr.veneto.it'}], 'facility': 'Unit of Cardiothoracic Anesthesia and Intensive Care, University hospital of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Federico Romagnosi, MD', 'role': 'CONTACT', 'email': 'federico.romagnosi@aovr.veneto.it', 'phone': '0458122621'}], 'overallOfficials': [{'name': 'Leonardo Gottin, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universita di Verona'}, {'name': 'Federico Romagnosi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}