DehydrationNCT00285285
Point of Care Device Use in the Pediatric Emergency Department
A study testing Point of Care Device; i-Stat Analyzer in people with Dehydration and Seizure, run by Yale University.
Trial summary
To compare the effect of "point-of-care" (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED). Read more about this study
- Who is it for?
- Ages 1 day to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Seizure, Gastroenteritis
- What is being tested?
- Point of Care Device; i-Stat Analyzer
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Aug 2004
- 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 1 day to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinically requiring bloodwork capable by the POC device
Who cannot join
- Requiring other bloodwork such as medication levels, WBC
About this study
Official title: A Randomized Trial to Assess the Efficacy of Point-of-Care Testing in Decreasing Length of Stay in a Pediatric Emergency Department
To compare the effect of "point-of-care" (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED).
Read the detailed description
This study was a prospective, randomized controlled study of patients requiring blood work that a POC device was capable of performing. Length of time spent at various timepoints were prospectively recorded by a dedicated research assistant after randomization.
- Conditions
- Dehydration, Seizure, Gastroenteritis, Hyperglycemia
- Being tested
- Point of Care Device; i-Stat Analyzer
- Keywords
- Point-of-care Testing, Pediatric Emergency Department, Length of Stay, Efficiency
- Medical subject headings
- Dehydration, Seizures, Gastroenteritis, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care Device; i-Stat AnalyzerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Length of Stay
Secondary outcomes (1)
Time length for results return, disposition decision, time in ED proper
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Yale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Karen A. Santucci, M. Douglas Baker, i-Stat Corporation
- Investigators
- M. Douglas Baker, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285285
- Sponsor's protocol ID
- 25448
- Status last verified
- Jan 2006
- First submitted
- 31 Jan 2006
- Last updated
- 1 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Assess the Efficacy of Point-of-Care Testing in Decreasing Length of Stay in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00285285
- Acronym / sponsor ID
- 25448
- Conditions
- Dehydration, Seizure, Gastroenteritis, Hyperglycemia
- Keywords
- Point-of-care Testing, Pediatric Emergency Department, Length of Stay, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Karen A. Santucci, M. Douglas Baker, i-Stat Corporation
- Study start
- Jan 2004
- Study completion
- Aug 2004
- First posted
- 1 Feb 2006 (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.
To compare the effect of "point-of-care" (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED).
Detailed description
This study was a prospective, randomized controlled study of patients requiring blood work that a POC device was capable of performing. Length of time spent at various timepoints were prospectively recorded by a dedicated research assistant after randomization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinically requiring bloodwork capable by the POC device
Key exclusion criteria (1 listed)
- Requiring other bloodwork such as medication levels, WBC
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 Device; i-Stat Analyzer | Device | – |
Primary outcome
Total Length of Stay
1 secondary outcome
Time length for results return, disposition decision, time in ED proper
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 1 Feb 2006.
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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Hydration & Female Life Stages
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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.
M. Douglas Baker, MD study director
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Point of Care Device; i-Stat Analyzer in people with Dehydration and Seizure, run by Yale University.
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 1 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 1 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Total Length of Stay. 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 1 Feb 2006.