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

Study Overview
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Brief Summary
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Light sedation<br>Light sedation is defined as RASS of +1 to -2. | |
| Deep sedation<br>Deep sedation is defined as RASS of -3 to -5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the diagnostic accuracy of BIS monitoring for detecting deep sedation against the reference standard of RASS. | 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. | 15 minutes before and after RASS evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of deep sedation | Number of participants with deep sedation according to RASS evaluation. | 24 hours after establishing of BIS monitoring |