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NCT00285285 Clinical Trial

Point of Care Device Use in the Pediatric Emergency Department

Hyperglycemia Clinical Trial

Official title:
A Randomized Trial to Assess the Efficacy of Point-of-Care Testing in Decreasing Length of Stay in a Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285285
Other study ID # 25448
Secondary ID
Status Completed
Phase N/A
First received January 31, 2006
Last updated January 31, 2006
Start date January 2004
Est. completion date August 2004

Study information
Verified date January 2006
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Clinically requiring bloodwork capable by the POC device

Exclusion Criteria:

- Requiring other bloodwork such as medication levels, WBC

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Point of Care Device; i-Stat Analyzer

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Yale University i-Stat Corporation, Karen A. Santucci, M. Douglas Baker

Outcome
Type Measure Description Time frame Safety issue
Primary Total Length of Stay
Secondary Time length for results return, disposition decision, time in ED proper
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