Intensive Care UnitNCT03975751
Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China
An observational study of Intensive Care Unit, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- The Glasgow Coma Scale (GCS)
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2019to 9 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All adult patients admitted to the participating ICUs on the investigation day
Who cannot join
- Age under 18 years
- Less than 24 hours of ICU stay before screening
- Taking part in other studies
Trial locations and contacts
1 site in 1 country.
China1 site
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: 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.
Read the 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.
- Conditions
- Intensive Care Unit
- Being tested
- The Glasgow Coma Scale (GCS)
- Keywords
- severe brain injuries, sedation and analgesia, intensive care unit, survey
- Medical subject headings
- Brain Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Glasgow Coma Scale (GCS)Diagnostic test
Also called The Richmond Agitation-Sedation Scale (RASS), The self-reported pain assessment
Use the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of sedation assessment
The percentage of patients receiving sedation assessment
Measured: The previous 24 hours prior to the on-site investigation
Performance of pain assessment
The percentage of patients receiving pain assessment
Measured: The previous 24 hours prior to the on-site investigation
Secondary outcomes (4)
Use of sedatives
The percentage of patients receiving sedatives
Measured: The previous 24 hours prior to the on-site investigation
Use of analgesics
The percentage of patients receiving analgesics
Measured: The previous 24 hours prior to the on-site investigation
ICU mortality
The percentage of patients dead in the ICU
Measured: Within 60 days after on-site investigation
Hospital mortality
The percentage of patients dead in the hospital
Measured: Within 60 days after on-site investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start8 Jan 2019
- Primary completion8 Jan 2019
- Study completion9 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975751
- Sponsor's protocol ID
- KY2017-062-02
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33627067
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey on the Practice of Sedation and Analgesia Among Patients With Severe Brain Injury in China: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03975751
- Acronym / sponsor ID
- KY2017-062-02
- Conditions
- Intensive Care Unit
- Keywords
- severe brain injuries, sedation and analgesia, intensive care unit, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients admitted to the participating ICUs on the investigation day
Key exclusion criteria (3 listed)
- Age under 18 years
- Less than 24 hours of ICU stay before screening
- Taking part in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Glasgow Coma Scale (GCS)Also: The Richmond Agitation-Sedation Scale (RASS), The self-reported pain assessmentUse the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia. | Diagnostic test | – |
Primary outcome
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
4 secondary outcomes
Use of sedatives
Time frame: 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
ICU mortality
Time frame: Within 60 days after on-site investigation
Hospital mortality
Time frame: Within 60 days after on-site investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 33627067Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Xin Zhou, MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of sedation assessment (time frame: The previous 24 hours prior to the on-site investigation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.