Evaluation of the Contribution of the Ultrasound Tracking... | NCT03133962

Studies
Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

NCT03133962

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Withdrawn

Last Update Posted

May 12, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Echocardiography
Implantable Chamber

Interventions

Adult patients who are candidates for a CAP or long-term central catheter placement

Countries

France

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

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision of the investigator

Expanded Access Info

Start Date

Nov 3, 2014Actual

Primary Completion Date

Apr 21, 2017Actual

Completion Date

Apr 21, 2017Actual

First Submitted Date

Apr 25, 2017

First Submission Date that Met QC Criteria

Apr 25, 2017

First Posted Date

Apr 28, 2017Actual

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

May 11, 2017

Last Update Posted Date

May 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.

The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency

Detailed Description

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients applying for CAP or long-term central catheter	Other		Other: Adult patients who are candidates for a CAP or long-term central catheter placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adult patients who are candidates for a CAP or long-term central catheter placement	Other	Evaluate the feasibility of finding the correct positioning of the distal end of the PAC or of the long-term catheter by cardiac ultrasound in comparison with the brightness scopy, reference method.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Good positioning of the distal end of the catheter by ETT, without repositioning following the scopy		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients are candidates for a long-term CAP or central catheter placement.
Benefiting from sedation or general anesthesia.

Exclusion Criteria:

Patient aged <18 years.
Pregnant woman.
Lack of anesthesiologist with knowledge of ultrasound.
Site of femoral puncture

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens Picardie		Amiens	Picardie	80054	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.