Evaluating Validity of Clinical Criteria for Requesting C... | NCT01134744

Studies
Evaluating Validity of Clinical Criteria for Requesting Chest X-Rays in Trauma Patients

NCT01134744

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Jun 22, 2010Estimated

Enrollment

385Actual

Phase

Not provided

Conditions

Chest Trauma

Interventions

Not provided

Countries

Iran

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

Oct 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

Oct 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

May 27, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

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

Jun 18, 2010

Last Update Posted Date

Jun 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.

Detailed Description

At present, a Chest x-ray is obtained from all trauma patients having suspicion to chest trauma. The indications for such radiographs are not well defined. This results in a large number of unnecessary chest radiographs being obtained. Our goal was to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.

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

385Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chest trauma		chest x-ray applied for patients with chest trauma and the manifestations compared with clinical examination

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chest pain	for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation	5 min after admision time

Secondary Outcomes

Measure	Description	Time Frame
tachypnea	for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation	5 min after admision time
abrasion	for Assessing the accuaracy of this outcome we evaluated this one with chest x-ray manifestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Every patient with blunt trauma to chest

Exclusion Criteria:

nothing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Three hundred and eighty six

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
hamidreza shemshaki, MD	MD,research comittee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-zahra university hospital		Isfahan		0311	Iran
Emamkhomeini University Hospital