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.

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Key information

Conditions

Disorder; Mental, Sedative Consciousness Disorders Depressed Level of Consciousness Mechanical Ventilation Complication Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychosis Associated With Intensive Care Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 102600, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Incidence of deep sedation

Time frame: 24 hours after establishing of BIS monitoring

Number of participants with deep sedation according to RASS evaluation.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: May 12, 2015
Registry last updated: Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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