Status:
COMPLETED
BIS Monitoring to Detect Deep Sedation
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
Beijing Municipal Health Bureau
Conditions:
Disorder; Mental, Sedative
Depressed Level of Consciousness
Eligibility:
All Genders
18-65 years
Brief Summary
Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes in adult intensive care unit (ICU) patients. The revised guidelines for management of pain, agitation and d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02203344
Start Date
August 1 2014
End Date
December 1 2014
Last Update
December 30 2014
Active Locations (1)
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1
Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 102600