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

June 3, 2019 updated by: Jian-Xin Zhou, Capital Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

387

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • ICU, Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of sedation assessment
Time Frame: The previous 24 hours prior to the on-site investigation
The percentage of patients receiving sedation assessment
The previous 24 hours prior to the on-site investigation
Performance of pain assessment
Time Frame: The previous 24 hours prior to the on-site investigation
The percentage of patients receiving pain assessment
The previous 24 hours prior to the on-site investigation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of sedatives
Time Frame: The previous 24 hours prior to the on-site investigation
The percentage of patients receiving sedatives
The previous 24 hours prior to the on-site investigation
Use of analgesics
Time Frame: The previous 24 hours prior to the on-site investigation
The percentage of patients receiving analgesics
The previous 24 hours prior to the on-site investigation
ICU mortality
Time Frame: Within 60 days after on-site investigation
The percentage of patients dead in the ICU
Within 60 days after on-site investigation
Hospital mortality
Time Frame: Within 60 days after on-site investigation
The percentage of patients dead in the hospital
Within 60 days after on-site investigation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Study Chair: Jian-Xin Zhou, MD, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2019

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

March 9, 2019

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2017-062-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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