NCT03975751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

Same day

First QC Date

June 2, 2019

Last Update Submit

June 3, 2019

Conditions

Keywords

severe brain injuriessedation and analgesiaintensive care unitsurvey

Outcome Measures

Primary Outcomes (2)

  • Performance of sedation assessment

    The percentage of patients receiving sedation assessment

    The previous 24 hours prior to the on-site investigation

  • Performance of pain assessment

    The percentage of patients receiving pain assessment

    The previous 24 hours prior to the on-site investigation

Secondary Outcomes (4)

  • Use of sedatives

    The previous 24 hours prior to the on-site investigation

  • Use of analgesics

    The previous 24 hours prior to the on-site investigation

  • ICU mortality

    Within 60 days after on-site investigation

  • Hospital mortality

    Within 60 days after on-site investigation

Interventions

Use the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia.

Also known as: The Richmond Agitation-Sedation Scale (RASS), The self-reported pain assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Brain InjuriesAgnosia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jian-Xin Zhou, MD

    Beijing Tiantan Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 5, 2019

Study Start

January 8, 2019

Primary Completion

January 8, 2019

Study Completion

March 9, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations