CompletedNCT02439840Updated Aug 5, 2015

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

An observational study in Disorder; Mental, Sedative, Depressed Level of Consciousness and Mechanical Ventilation Complication, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-05.

Sponsored by Capital Medical University · Observational

Study type: Observational
Time perspective: Prospective
Enrollment: 45
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

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

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In context

Consciousness Disorders

236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.

This study's enrollment of 45 is below the median of 79 across 86 observational studies indexed under Consciousness Disorders.

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Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

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

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

Time perspective: Prospective
Enrollment: 45 participants (actual)
Patient registry: No

Groups and cohorts

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 researchers measure

Primary outcomes

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.
Time frame: 15 minutes before and after RASS evaluation

Secondary outcomes

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

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02439840
Lead sponsor: Capital Medical University
Responsible party: Jian-Xin Zhou (Professor, Capital Medical University) — Principal investigator
First posted: May 12, 2015
Start date: Mar 2015
Primary completion: Jul 2015
Completion: Aug 2015
Last update: Aug 5, 2015

Study contacts

Jian-Xin Zhou, MD

principal investigator · Capital Medical University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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