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Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China

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ClinicalTrials.gov Identifier: NCT03975751
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Brief Summary:
Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies.

Condition or disease Intervention/treatment
Intensive Care Unit Diagnostic Test: The Glasgow Coma Scale (GCS)

Detailed Description:
Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies. In the present study, a multicenter, 1‐day point cross‐sectional study about the sedation and analgesia among patients in China, particularly brain‐injured will be investigated. The objectives are to investigate sedation and analgesia among patients in China and to compare sedation and analgesia between brain injuries and other patients.

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Study Type : Observational
Actual Enrollment : 387 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Survey on the Practice of Sedation and Analgesia Among Patients With Severe Brain Injury in China: a Prospective Observational Study
Actual Study Start Date : January 8, 2019
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : March 9, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: The Glasgow Coma Scale (GCS)
    Use the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia.
    Other Names:
    • The Richmond Agitation-Sedation Scale (RASS)
    • The self-reported pain assessment


Primary Outcome Measures :
  1. Performance of sedation assessment [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving sedation assessment

  2. Performance of pain assessment [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving pain assessment


Secondary Outcome Measures :
  1. Use of sedatives [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving sedatives

  2. Use of analgesics [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving analgesics

  3. ICU mortality [ Time Frame: Within 60 days after on-site investigation ]
    The percentage of patients dead in the ICU

  4. Hospital mortality [ Time Frame: Within 60 days after on-site investigation ]
    The percentage of patients dead in the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients at 9am on the on-site investigation day in the participating ICUs will be screened and enrolled according to the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  • All adult patients admitted to the participating ICUs on the investigation day

Exclusion Criteria:

  • Age under 18 years
  • Less than 24 hours of ICU stay before screening
  • Taking part in other studies

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): NCT03975751


Locations
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China, Beijing
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Investigators
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Study Chair: Jian-Xin Zhou, MD Beijing Tiantan Hospital

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Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03975751     History of Changes
Other Study ID Numbers: KY2017-062-02
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jian-Xin Zhou, Capital Medical University:
severe brain injuries
sedation and analgesia
intensive care unit
survey

Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries