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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439840
• Other study ID #: MCS-2015-001
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: August 4, 2015
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of deep sedation	Number of participants with deep sedation according to RASS evaluation.	24 hours after establishing of BIS monitoring	No