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Point of Care Device Use in the Pediatric Emergency Department

Primary Purpose

Dehydration, Seizure, Gastroenteritis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Point of Care Device; i-Stat Analyzer

About this trial

This is an interventional diagnostic trial for Dehydration focused on measuring Point-of-care Testing, Pediatric Emergency Department, Length of Stay, Efficiency

Eligibility Criteria

1 Day - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinically requiring bloodwork capable by the POC device Exclusion Criteria: Requiring other bloodwork such as medication levels, WBC

Sites / Locations

Outcomes

Primary Outcome Measures

Total Length of Stay

Secondary Outcome Measures

Time length for results return, disposition decision, time in ED proper

Full Information

NCT ID

NCT00285285

First Posted

January 31, 2006

Last Updated

January 31, 2006

Sponsor

Yale University

Collaborators

Karen A. Santucci, M. Douglas Baker, i-Stat Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00285285

Brief Title

Point of Care Device Use in the Pediatric Emergency Department

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Yale University

Collaborators

Karen A. Santucci, M. Douglas Baker, i-Stat Corporation

4. Oversight

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dehydration, Seizure, Gastroenteritis, Hyperglycemia

Keywords

Point-of-care Testing, Pediatric Emergency Department, Length of Stay, Efficiency

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Point of Care Device; i-Stat Analyzer

Primary Outcome Measure Information:

Title

Total Length of Stay

Secondary Outcome Measure Information:

Title

Time length for results return, disposition decision, time in ED proper

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically requiring bloodwork capable by the POC device Exclusion Criteria: Requiring other bloodwork such as medication levels, WBC

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M. Douglas Baker, MD

Organizational Affiliation

Yale University

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Point of Care Device Use in the Pediatric Emergency Department

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