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出境医 / 临床实验 / Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 2, 2019
First Posted Date June 5, 2019
Last Update Posted Date June 5, 2019
Actual Study Start Date January 8, 2019
Actual Primary Completion Date January 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2019)
  • Performance of sedation assessment [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving sedation assessment
  • Performance of pain assessment [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving pain assessment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 3, 2019)
  • Use of sedatives [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving sedatives
  • Use of analgesics [ Time Frame: The previous 24 hours prior to the on-site investigation ]
    The percentage of patients receiving analgesics
  • ICU mortality [ Time Frame: Within 60 days after on-site investigation ]
    The percentage of patients dead in the ICU
  • Hospital mortality [ Time Frame: Within 60 days after on-site investigation ]
    The percentage of patients dead in the hospital
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China
Official Title A Survey on the Practice of Sedation and Analgesia Among Patients With Severe Brain Injury in China: a Prospective Observational Study
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Intensive Care Unit
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.
Other Names:
  • The Richmond Agitation-Sedation Scale (RASS)
  • The self-reported pain assessment
Study Groups/Cohorts Not Provided
Publications * Chen K, Yang YL, Li HL, Xiao D, Wang Y, Zhang L, Zhou JX. A gap existed between physicians' perceptions and performance of pain, agitation-sedation and delirium assessments in Chinese intensive care units. BMC Anesthesiol. 2021 Feb 25;21(1):61. doi: 10.1186/s12871-021-01286-w.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2019) 		387
Original Actual Enrollment Same as current
Actual Study Completion Date March 9, 2019
Actual Primary Completion Date January 8, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03975751
Other Study ID Numbers KY2017-062-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jian-Xin Zhou, Capital Medical University
Study Sponsor Capital Medical University
Collaborators Not Provided
Investigators
Study Chair: Jian-Xin Zhou, MD Beijing Tiantan Hospital
PRS Account Capital Medical University
Verification Date June 2019

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