Point of Care Device Use in the Pediatric Emergency Department
This study has been completed.
Sponsor:
Yale University
Collaborators:
Karen A. Santucci
M. Douglas Baker
i-Stat Corporation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00285285
First received: January 31, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2006 | ||||
| Last Updated Date | January 31, 2006 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Total Length of Stay | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Time length for results return, disposition decision, time in ED proper | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Point of Care Device Use in the Pediatric Emergency Department | ||||
| Official Title ICMJE | A Randomized Trial to Assess the Efficacy of Point-of-Care Testing in Decreasing Length of Stay in a Pediatric Emergency Department | ||||
| Brief 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Point of Care Device; i-Stat Analyzer | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | August 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00285285 | ||||
| Other Study ID Numbers ICMJE | 25448 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | January 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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