Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement (VVC)

September 11, 2014 updated by: Centre Leon Berard

Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study

It is an observational, prospective, monocentric study. The purpose of the study is to assess the acute complications rate caused by a central venous catheter placement.

All the patients who require a central venous placement could be enrolled in the study.

The study will not change the usual practice. The placement will be on day 1 and patients will be contacted by phone on day 7 to identify potential complications and to assess pain.

Anaesthesia staff will keep patients under surveillance to control the absence of late complications.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1780

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • LYON Cedex 08, France, 69373
        • Centre Leon Berard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patient who require the placement of a central venous catheter

Description

Inclusion Criteria:

  • Age >= 18.
  • Patient who requires the placement of a central venous catheter (a portacath (PAC), a peripherally inserted central catheter (PICC) or a tunnelled catheter).
  • Patient able to understand, read and write French.
  • Mandatory affiliation with a health insurance system.

Exclusion Criteria:

  • Active infection at placement of the central venous catheter.
  • Patient who can't be contacted by phone.
  • Patient who is likely to have a femoral venous catheter placement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Central venous catheter
All patients who require the placement of a central venous catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the acute complications rate
Time Frame: From day 1 to day 7
Placement of the central venous catheter on day 1 and follow-up of potential acute complications
From day 1 to day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the preoperative anxiety
Time Frame: On day 1
By means of Beck anxiety inventory
On day 1
Assess patients satisfaction about the catheter
Time Frame: On day 7
By means of a questionnary filled in by patients at home
On day 7
Assess postoperative pain
Time Frame: On day 1 and on day 7
The pain will be assessed on day 1 by a visual analogic scale and on day 7 by a verbal numeric scale
On day 1 and on day 7
Assess the rate of late complications
Time Frame: Up to 1 year
The anaesthesia staff will keep patients under surveillance for potential late complications.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (ESTIMATE)

July 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VVC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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