Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-11 @ 8:57 AM
Study NCT ID:
NCT01760369
Status:
COMPLETED
Last Update Posted:
2013-11-14
First Post:
2012-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-13', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in regional cerebral oxygenation (rSO2)', 'timeFrame': '1 day', 'description': 'Before, during and immediately after awaking from anesthesia'}], 'secondaryOutcomes': [{'measure': 'Post anesthetic complications', 'timeFrame': '1 day', 'description': 'During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Regional Cerebral Oxygen Saturation During Head Rotation']}, 'referencesModule': {'references': [{'pmid': '24335413', 'type': 'DERIVED', 'citation': 'Andersen JD, Baake G, Wiis JT, Olsen KS. Effect of head rotation during surgery in the prone position on regional cerebral oxygen saturation: A prospective controlled study. Eur J Anaesthesiol. 2014 Feb;31(2):98-103. doi: 10.1097/EJA.0000000000000028.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower back surgery\n* Age \\[18-80\\]\n* ASA group I-III\n* free and painless movement of the neck (including flexion, extension and rotation)\n\nExclusion Criteria:\n\n* Pain during neck movement as mentioned under inclusion criteria.\n* known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease\n* any stenosis of the carotid vessels or known symptoms associated with such\n* BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT01760369', 'acronym': 'NIRS', 'briefTitle': 'Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.', 'orgStudyIdInfo': {'id': 'NIRS-JDHA-12'}}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup kommune', 'country': 'Denmark', 'facility': 'Glostrup Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Johnny DH Andersen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Johnny Andersen', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}