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OpenTrials
Completed

NCT Number: NCT00273169

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

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

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 9, 2006
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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