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

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ClinicalTrials.gov Identifier: NCT02439840
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

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.

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

Study Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Prospective
Official Title: Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Group/Cohort
Light sedation
Light sedation is defined as RASS of +1 to -2.
Deep sedation
Deep sedation is defined as RASS of -3 to -5



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of deep sedation [ Time Frame: 24 hours after establishing of BIS monitoring ]
    Number of participants with deep sedation according to RASS evaluation.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439840


Locations
China, Beijing
Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University
Beijing, Beijing, China, 102600
Sponsors and Collaborators
Capital Medical University
Investigators
Principal Investigator: Jian-Xin Zhou, MD Capital Medical University

Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02439840     History of Changes
Other Study ID Numbers: MCS-2015-001
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Mental Disorders
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders