Standard Length Catheters vs Long Catheters in Peripheral... | NCT01917253

Studies
Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation.

NCT01917253

Sponsor

ASL TO2 Torino

Status

Unknown status

Last Update Posted

Aug 6, 2013Estimated

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Complications

Interventions

Standard Device for peripheral vein cannulation
Long Catheters for peripheral vein cannulation

Countries

Italy

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Oct 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Aug 5, 2013

First Submission Date that Met QC Criteria

Aug 5, 2013

First Posted Date

Aug 6, 2013Estimated

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

Aug 5, 2013

Last Update Posted Date

Aug 6, 2013Estimated

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 Long and Short is a prospective, randomized, controlled, open label trial to test the complications of different device for peripheral vein cannulation, standard length (about 5 cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique.

Detailed Description

The trial will compare the main complications: infiltration rate, phlebitis rate, occlusion and/or dislocation rate, thrombosis rate, number of percutaneous sticks, successful cannulation.

Will be made for a cost analysis.

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

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard length catheter	Experimental	Standard Device for peripheral vein cannulation	Device: Standard Device for peripheral vein cannulation
Long catheter	Experimental	Standard Device for peripheral vein cannulation	Device: Long Catheters for peripheral vein cannulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Device for peripheral vein cannulation	Device		standard length catheter
Long Catheters for peripheral vein cannulation

Measure	Description	Time Frame
complications rate		3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients
infusional therapy more than 72 hours

Exclusion Criteria:

need for central venous catheter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tiziana De Prospo	Contact	+39 011 439	5739	tiziana.deprospo@aslto2.piemonte.it

Overall Officials

Name	Affiliation	Role
Piero Riva, MD	ASLTO2- MECAU- Maria Vittoria Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MECAU-Maria Vittoria Hospital	Recruiting	Torino	Torino	10141	Italy

Condition Browse Module

MeSH Terms

ID	Term
D010689	Phlebitis
D001733	Bites and Stings
D013927	Thrombosis

Ancestor Terms

ID	Term
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D014657	Vasculitis

Browse Leaves

Not provided

Browse Branches

Not provided