Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery

Postoperative Clinical Trial

Official title:

Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273169
• Other study ID #: 110-05
• Status: Completed
• Phase: N/A
• First received: January 6, 2006
• Last updated: January 14, 2010
• Start date: July 2005
• Est. completion date: September 2008

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Postoperative

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,