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NCT03975751 Clinical Trial

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

Intensive Care Unit Clinical Trial

Official title:
A Survey on the Practice of Sedation and Analgesia Among Patients With Severe Brain Injury in China: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03975751
Other study ID # KY2017-062-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 8, 2019
Est. completion date March 9, 2019

Study information
Verified date June 2019
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 387
Est. completion date March 9, 2019
Est. primary completion date January 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China ICU, Beijing Tiantan 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 Performance of sedation assessment The percentage of patients receiving sedation assessment The previous 24 hours prior to the on-site investigation
Primary Performance of pain assessment The percentage of patients receiving pain assessment The previous 24 hours prior to the on-site investigation
Secondary Use of sedatives The percentage of patients receiving sedatives The previous 24 hours prior to the on-site investigation
Secondary Use of analgesics The percentage of patients receiving analgesics The previous 24 hours prior to the on-site investigation
Secondary ICU mortality The percentage of patients dead in the ICU Within 60 days after on-site investigation
Secondary Hospital mortality The percentage of patients dead in the hospital Within 60 days after on-site investigation
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