Point-Of-Care Chemistry Test (POCT) Effect on the Emergen... | NCT00942955

Studies
Point-Of-Care Chemistry Test (POCT) Effect on the Emergency Department (ED)

NCT00942955

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 21, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Emergency Department
Length of Stay
Turnaround-time

Interventions

Not provided

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

Jul 2009

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 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jul 20, 2009

First Submission Date that Met QC Criteria

Jul 20, 2009

First Posted Date

Jul 21, 2009Estimated

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

Jul 20, 2009

Last Update Posted Date

Jul 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The hypothesis of this study is that POCT will shorten ED turn-around-time (TAT) such as blood drawing TAT, lab TAT, and decision TAT.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CLT		The patients whose blood are analyzed by conventional central laboratory.
POCT		the patients group whose lab analyze by POCT device.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 15 years
clinically required to have chemistry lab tests
agreement

Exclusion Criteria:

no agreement
ESI level 1

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This study was performed in five EDs. Three were urban EDs with 30,000 to 45,000 annual visits, and two were suburban EDs with 15,000 to 25,000 annual visits. Each hospital has its own central laboratory which can test the same emergency chemistry tests, including liver panel (alkaline phosphatase, protein, albumin, total bilirubin, direct bilirubin, GOT, and GPT), renal panel (BUN, creatinine, calcium, and phosphorus), pancreas enzymes (amylase, lipase), electrolytes (sodium, potassium, chloride, total CO2), lipid panel (total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol), and blood gases (pH, pO2, pCO2, and bicarbonate).

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided