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Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery
This study is currently recruiting participants.
Verified by Mayo Clinic, January 2006
First Received: January 6, 2006   No Changes Posted
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00273169
  Purpose

Evaluate correlation between the values from the PSA monitor and clinical assessment of sedation with the RASS on postoperative patients.


Condition
Postoperative

Study Type: Observational
Study Design: Natural History, Longitudinal, Convenience Sample, Prospective Study
Official Title: Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Estimated Enrollment: 50
Study Start Date: July 2005
Estimated Study Completion Date: October 2005
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273169

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Francis X Whalen     507-255-5432     whalen.francis@mayo.edu    
Principal Investigator: Francis x Whalen, M.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Francis X. Whalen, Jr., M.D. Mayo Clinic
  More Information

No publications provided

Study ID Numbers: 110-05
Study First Received: January 6, 2006
Last Updated: January 6, 2006
ClinicalTrials.gov Identifier: NCT00273169     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 01, 2009