CrowdingPOCTEDNCT01402635
Can the Point-Of-Care Chemistry Test (POCT) Solve the Emergency Department (ED) Crowding?
A study testing point-of-care chemistry test(POCT) (Piccolo) in people with Crowding, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten Emergency Department (ED) length of stay (LOS). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Crowding
- What is being tested?
- point-of-care chemistry test(POCT) (Piccolo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,244 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Aug 2011
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 15 years
- clinically required to have chemistry lab tests
- ESI 2-5
- written agreement to participate
Who cannot join
- no agreement
- ESI level 1
- no chemistry lab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Central Laboratory and Point-of-care Chemistry Test for Solving the Emergency Department Crowding
The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten Emergency Department (ED) length of stay (LOS).
Read the detailed description
ED crowding is one of the most serious problems in ED. POCT has shorter turn-around time compared to centralized laboratory system. If POCT introduce to ED, it may help to shorten LOS of ED patients.
- Conditions
- Crowding
- Being tested
- point-of-care chemistry test(POCT) (Piccolo)
- Keywords
- crowding, Point-of-Care Systems, emergency medicine
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point-of-care chemistry test(POCT) (Piccolo)Device
Also called Piccolo® xpress, Piccolo® Comprehensive Metabolic Reagent Disc
comprehensive chemistry POCT including ALB, ALP, ALT, AST, BUN, Ca, Cl-, Cre, Glu, K+, Na+, TBil, TCO2, TP It takes 12minutes to perform analyze.
| Study group | Role | What they receive |
|---|---|---|
| POCT lab | Experimental | The patient group whose laboratory test perform by POCT chemistry analyzer. Receives: Device: point-of-care chemistry test(POCT) (Piccolo) |
| central laboratory group(CLT) | Active comparator | The patients group whose laboratory test perform by central laboratory. Receives: Device: point-of-care chemistry test(POCT) (Piccolo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay
Time interval between registration at ED and leaving at ED(discharge, admission, etc.)
Measured: average 7days from ED visit(up to time of discharge at ED or admission to ward)
Secondary outcomes (1)
length of stay(subgroup)
length of stay analysis for Emergency Severity Index (ESI) 3-4, admission or discharge group
Measured: average 7days from ED visit (up to time of discharge at ED or admission to ward)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
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 CrowdingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Do Shin, Seoul National University Hospital
- Investigators
- Sang Do Shin, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402635
- Sponsor's protocol ID
- SNUEMS201101
- Acronym
- POCTED
- Status last verified
- Jul 2012
- First submitted
- 9 Jan 2011
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee EJ, Shin SD, Song KJ, Kim SC, Cho JS, Lee SC, Park JO, Cha WC. A point-of-care chemistry test for reduction of turnaround and clinical decision time. Am J Emerg Med. 2011 Jun;29(5):489-95. doi: 10.1016/j.ajem.2009.11.020. Epub 2010 Apr 24.
PubMed 20825817
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Central Laboratory and Point-of-care Chemistry Test for Solving the Emergency Department Crowding
- ClinicalTrials.gov ID
- NCT01402635
- Acronym / sponsor ID
- POCTED / SNUEMS201101
- Conditions
- Crowding
- Keywords
- crowding, Point-of-Care Systems, emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,244 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- 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.
The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten Emergency Department (ED) length of stay (LOS).
Detailed description
ED crowding is one of the most serious problems in ED. POCT has shorter turn-around time compared to centralized laboratory system. If POCT introduce to ED, it may help to shorten LOS of ED patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCT lab | Experimental | Device: point-of-care chemistry test(POCT) (Piccolo)The patient group whose laboratory test perform by POCT chemistry analyzer. |
| central laboratory group(CLT) | Active comparator | Device: point-of-care chemistry test(POCT) (Piccolo)The patients group whose laboratory test perform by central laboratory. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 15 years
- clinically required to have chemistry lab tests
- ESI 2-5
- written agreement to participate
Key exclusion criteria (3 listed)
- no agreement
- ESI level 1
- no chemistry lab
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 |
|---|---|---|
| point-of-care chemistry test(POCT) (Piccolo)Also: Piccolo® xpress, Piccolo® Comprehensive Metabolic Reagent Disccomprehensive chemistry POCT including ALB, ALP, ALT, AST, BUN, Ca, Cl-, Cre, Glu, K+, Na+, TBil, TCO2, TP It takes 12minutes to perform analyze. | Device | POCT lab, central laboratory group(CLT) |
Primary outcome
length of stay
Time frame: average 7days from ED visit(up to time of discharge at ED or admission to ward)
Time interval between registration at ED and leaving at ED(discharge, admission, etc.)
1 secondary outcome
length of stay(subgroup)
Time frame: average 7days from ED visit (up to time of discharge at ED or admission to ward)
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 24 Jul 2012.
- Background: PubMed 20825817Lee EJ, Shin SD, Song KJ, Kim SC, Cho JS, Lee SC, Park JO, Cha WC. A point-of-care chemistry test for reduction of turnaround and clinical decision time. Am J Emerg Med. 2011 Jun;29(5):489-95. doi: 10.1016/j.ajem.2009.11.020. Epub 2010 Apr 24.
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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.
Sang Do Shin, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing point-of-care chemistry test(POCT) (Piccolo) in people with Crowding, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 24 Jul 2012. 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 South Korea. 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?
length of stay (time frame: average 7days from ED visit(up to time of discharge at ED or admission to ward)). 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 NCT01402635, 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 24 Jul 2012.