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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102600
      • Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients admitted to 3 ICUs in University Affiliated Hospital will be screened daily and enrolled consecutively.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Light sedation; Light sedation is defined as RASS of +1 to -2.
Deep sedation; Deep sedation is defined as RASS of -3 to -5

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Jian-Xin Zhou, MD, Capital Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Mental Disorders; Consciousness Disorders
• Other Study ID Numbers: MCS-2015-001