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

NCT ID: NCT02439840

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-31

Brief 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

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Light sedation

Light sedation is defined as RASS of +1 to -2.

No interventions assigned to this group

Deep sedation

Deep sedation is defined as RASS of -3 to -5

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

MCS-2015-001

Identifier Type: -

Identifier Source: org_study_id