EmergenciesNCT03926234
Effectiveness of a Four-level Chinese Emergency Triage Scale in Mainland China
An observational study of Emergencies and Triage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Inter-rater reliability between experts and triage nurses was assessed in 484 emergency patients. The criterion-related validity was evaluated in other 30687 emergency patients, based on emergency department (ED) mortality, the length of stay in ED, the number of discharge, and hospitalization (intensive care/general… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Emergencies, Triage
- What is being tested?
- Four-level Chinese Emergency triage scale
- Type of treatment
- Injection or infusion
- How many people
- 30,687 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eligibility emergency patients
Who may be able to join
- Patients, older than 14 years and admitted to the ED, were eligible for this study.
Who cannot join
- Gynecologic and obstetric emergencies
- Patients, who left against medical advice or hadn't been aided by a doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability and Validity of a Four-level Chinese Emergency Triage Scale in Mainland China
Inter-rater reliability between experts and triage nurses was assessed in 484 emergency patients. The criterion-related validity was evaluated in other 30687 emergency patients, based on emergency department (ED) mortality, the length of stay in ED, the number of discharge, and hospitalization (intensive care/general ward).
- Conditions
- Emergencies, Triage
- Being tested
- Four-level Chinese Emergency triage scale
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-level Chinese Emergency triage scaleOther
a four-level category system, i.e. life-threatening (Level I), emergent (Level II), urgent (Level III) and semi-urgent (Level IV) . This system contains critical indicators (cardiac arrest, shock, and apnea), high risk indicators (ACS and DKA), single objective indicators (SBP, RR, HR, and SpO2) and MEWS (synthesis indicator). According to patients' health care problems, patients are rated by nurses into one of the four mentioned levels.
| Study group | Role | What they receive |
|---|---|---|
| emergency triage patients | triage Level I triage Level II triage Level III triage Level IV Receives: Other: Four-level Chinese Emergency triage scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability
inter-rater reliability as the agreement between triage nurses and experts
Measured: 2019-10-1
emergency department (ED) mortality
Measured: 2019-12-31
the number of discharge
Measured: 2019-12-31
Secondary outcomes (1)
the number of hospitalization
Measured: 2019-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,687 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Tongji Hospital, Henan Provincial People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, First People's Hospital of Hangzhou, Second People's Hospital of Hangzhou, Changxing People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926234
- Sponsor's protocol ID
- 2018ZH012
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of a Four-level Chinese Emergency Triage Scale in Mainland China
- ClinicalTrials.gov ID
- NCT03926234
- Acronym / sponsor ID
- 2018ZH012
- Conditions
- Emergencies, Triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,687 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Tongji Hospital, Henan Provincial People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, First People's Hospital of Hangzhou, Second People's Hospital of Hangzhou, Changxing People's Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 24 Apr 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.
Inter-rater reliability between experts and triage nurses was assessed in 484 emergency patients. The criterion-related validity was evaluated in other 30687 emergency patients, based on emergency department (ED) mortality, the length of stay in ED, the number of discharge, and hospitalization (intensive care/general ward).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| emergency triage patients | – | Other: Four-level Chinese Emergency triage scaletriage Level I triage Level II triage Level III triage Level IV |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligibility emergency patients
Key inclusion criteria (1 listed)
- Patients, older than 14 years and admitted to the ED, were eligible for this study.
Key exclusion criteria (2 listed)
- Gynecologic and obstetric emergencies
- Patients, who left against medical advice or hadn't been aided by a doctor
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 |
|---|---|---|
| Four-level Chinese Emergency triage scalea four-level category system, i.e. life-threatening (Level I), emergent (Level II), urgent (Level III) and semi-urgent (Level IV) . This system contains critical indicators (cardiac arrest, shock, and apnea), high risk indicators (ACS and DKA), single objective indicators (SBP, RR, HR, and SpO2) and MEWS (synthesis indicator). According to patients' health care problems, patients are rated by nurses into one of the four mentioned levels. | Other | emergency triage patients |
Primary outcome
Inter-rater reliability
Time frame: 2019-10-1
inter-rater reliability as the agreement between triage nurses and experts
emergency department (ED) mortality
Time frame: 2019-12-31
the number of discharge
Time frame: 2019-12-31
1 secondary outcome
the number of hospitalization
Time frame: 2019-12-31
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 18 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Emergencies and Triage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 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 18 Jun 2021. 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?
Inter-rater reliability (time frame: 2019-10-1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.