Point of Care Device Use in the Pediatric Emergency Depar... | NCT00285285

Studies
Point of Care Device Use in the Pediatric Emergency Department

NCT00285285

Sponsor

Yale University

Status

Completed

Last Update Posted

Feb 1, 2006Estimated

Enrollment

200

Phase

Not Applicable

Conditions

Dehydration
Seizure
Gastroenteritis
Hyperglycemia

Interventions

Point of Care Device; i-Stat Analyzer

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Aug 2004

First Submitted Date

Jan 31, 2006

First Submission Date that Met QC Criteria

Jan 31, 2006

First Posted Date

Feb 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2006

Last Update Posted Date

Feb 1, 2006Estimated

Name	Class
Karen A. Santucci	UNKNOWN
M. Douglas Baker	UNKNOWN
i-Stat Corporation	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Point of Care Device; i-Stat Analyzer	Device

Measure	Description	Time Frame
Total Length of Stay

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically requiring bloodwork capable by the POC device

Exclusion Criteria:

Requiring other bloodwork such as medication levels, WBC

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
M. Douglas Baker, MD	Yale University	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration
D012640	Seizures
D005759	Gastroenteritis
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided