Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study

Completed

• Conditions: Depressed Level of Consciousness; Psychosis Associated With Intensive Care; Disorder; Mental, Sedative; Mechanical Ventilation Complication

• Registration Number: NCT02439840
• Lead Sponsor: Capital Medical University

Brief Summary

In the previous study, the investigators obtained the cutoff value of Bispectral Index to detect early deep sedation in patients with mechanical ventilation. Bispectral Index monitoring can be used as an adjunct tool in screening and confirming deep sedation during the early period of mechanical ventilation. In present study, validation test will be carried out to clarify the sensitivity and specificity of obtained cutoff value in screening deep sedation in patients with mechanical ventilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-12
• Primary Completion: 2015-07
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours

Exclusion Criteria

• Age under 18 or over 65 years;
• Continuously infusion of muscle relaxants;
• Diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis;
• Diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmHg, hypotension with systolic blood pressure less than 90 mmHg, hypoglycemia with blood glucose concentration less than 4.1 mmol/L, anemia with hemoglobin concentration less than 70 g/L, and body temperature below 36 °C.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the diagnostic accuracy of BIS monitoring for detecting deep sedation against the reference standard of RASS.	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of deep sedation	24 hours after establishing of BIS monitoring	Number of participants with deep sedation according to RASS evaluation.

Trial Locations

Locations (1)

Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China