Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study
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|ClinicalTrials.gov Identifier: NCT02439840|
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : August 5, 2015
|Condition or disease|
|Disorder; Mental, Sedative Depressed Level of Consciousness Mechanical Ventilation Complication Psychosis Associated With Intensive Care|
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Light sedation is defined as RASS of +1 to -2.
Deep sedation is defined as RASS of -3 to -5
- To determine the diagnostic accuracy of BIS monitoring for detecting deep sedation against the reference standard of RASS. [ Time Frame: 15 minutes before and after RASS evaluation ]According to RASS evaluation, observations in each time point will be stratified into 2 situations: light sedation (RASS= 0 to -2) and deep sedation (RASS= -3 to -5). Diagnostic test analysis will be applied to determine the accuracy of BIS values in predicting deep sedation.
- Incidence of deep sedation [ Time Frame: 24 hours after establishing of BIS monitoring ]Number of participants with deep sedation according to RASS evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439840
|Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University|
|Beijing, Beijing, China, 102600|
|Principal Investigator:||Jian-Xin Zhou, MD||Capital Medical University|