Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT00273169
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2006-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-14', 'studyFirstSubmitDate': '2006-01-06', 'studyFirstSubmitQcDate': '2006-01-06', 'lastUpdatePostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Postoperative']}, 'descriptionModule': {'briefSummary': 'Evaluate correlation between the values from the PSA monitor and clinical assessment of sedation with the RASS on postoperative patients.', 'detailedDescription': 'Assessing level of sedation in critically ill patients is an integral part of intensive care practice. Sedation scales, such as the Richmond Agitation-Sedation Score (RASS) 1, have been developed, but are imperfect in a general population and of limited use when muscle relaxants are administered. Instruments have been developed to examine cerebral electrical activity using processed EEG in an attempt to determine state of awareness.2 The Bispectral Index (BIS) is a statistically derived measure of cerebral electrical activity to assess cortical-subcortical interaction. The BIS was determined by repeated studies on patients anesthetized in the operating room (OR) with the assumption that sedation is associated with a lack of awareness and recall.2 The Patient State Analyzer (PSA 4000) is a 4-channel processed EEG reading using an advanced algorithm that interprets changes in regional brain activity providing a numerical assessment (ranging from 0-100; 0 = no central nervous system \\[CNS\\] activity, 100 = awake) to assess the degree of sedation. The PSA 4000 (PSA) is an advancement over the BIS monitor as the BIS is a single channel whereas the PSA is a 4-channel monitor. Additionally, the PSA monitor has new proprietary software for analysis of the EEG data. The PSA is relatively new and thus there is little published data to evaluate its use in the operating room (OR) or the intensive care unit (ICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Detailed Population Description: The study population will include those patients that have undergone surgery under general anesthesia at St. Marys Hospital, Mayo Clinic Rochester, admitted to the 7MB D/E Intensive Care Unit and require intubation and mechanical ventilation for a period of at least 4 hours after admission', 'healthyVolunteers': False, 'eligibilityCriteria': 'Detailed Population Description: The study population will include those patients that have undergone surgery under general anesthesia at St. Marys Hospital, Mayo Clinic Rochester, admitted to the 7MB D/E Intensive Care Unit and require intubation and mechanical ventilation for a period of at least 4 hours after admission'}, 'identificationModule': {'nctId': 'NCT00273169', 'briefTitle': 'Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery', 'orgStudyIdInfo': {'id': '110-05'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Francis X. Whalen, Jr., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}}}}