Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT03107260
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of POCD', 'timeFrame': '72 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Saturation', 'Cognitive Impairment', 'Emergencies']}, 'descriptionModule': {'briefSummary': 'There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.\n\nAge is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* Non-cardiac, thoracic and vascular emergency surgery\n* Surgery under general anesthesia\n* ASA I, II or III\n* Simple information without consent\n* Patient affiliated to social security\n\nExclusion Criteria:\n\n* Inability to understand\n* Patient under tutelage, or curatorship or deprived of public right\n* ASA IV\n* History of severe dementia MMSE \\<20\n* Personal or familial history of malignant hyperthermia\n* History of allergy or hypersensitivity to anesthetic products used\n* Contra-indication to Cisatracurium®: myasthenia gravis\n* Contra-indication to Sevoflurane®\n* Contra-indication to local anesthetics\n* Indication of use of a Ketamine®-type hypnotic (modification of the BIS)\n* Indication of use of nitrous oxide\n* History of cranial trauma\n* Neuromuscular pathology\n* Spinal anesthesia\n* Cardiac, thoracic or vascular surgery\n* Surgery not performed in emergency\n* Neurochirugia in the context of cranial trauma\n* Any surgery that does not allow the use of the NIRS (impossibility of positioning of the electrodes by the location of the surgical field).'}, 'identificationModule': {'nctId': 'NCT03107260', 'acronym': 'NIRS-1', 'briefTitle': 'The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.', 'orgStudyIdInfo': {'id': 'PI2015_843_0018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Occurrence of postoperative cognitive dysfunction', 'interventionNames': ['Other: To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients']}], 'interventions': [{'name': 'To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients', 'type': 'OTHER', 'description': 'Evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in non-cardiac, thoracic and vascular emergency surgery in patients 65 years of age and older. The occurrence of POCD will be defined by the MMSE decrease of at least 4 points at 24, 48 or 72 hours', 'armGroupLabels': ['Occurrence of postoperative cognitive dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre NTOUBA, Dr', 'role': 'CONTACT', 'email': 'ntouba.alexandre@chu-amiens.fr', 'phone': '+33322668370'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Alexandre NTOUBA, Dr', 'role': 'CONTACT', 'email': 'ntouba.alexandre@chu-amiens.fr', 'phone': '+33322668370'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}