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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01405534
First received: July 28, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition
Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Estimate the acute complications rate [ Time Frame: From day 1 to day 7 ] [ Designated as safety issue: No ]
    Placement of the central venous catheter on day 1 and follow-up of potential acute complications


Secondary Outcome Measures:
  • Assess the preoperative anxiety [ Time Frame: On day 1 ] [ Designated as safety issue: No ]
    By means of Beck anxiety inventory

  • Assess patients satisfaction about the catheter [ Time Frame: On day 7 ] [ Designated as safety issue: No ]
    By means of a questionnary filled in by patients at home

  • Assess postoperative pain [ Time Frame: On day 1 and on day 7 ] [ Designated as safety issue: No ]
    The pain will be assessed on day 1 by a visual analogic scale and on day 7 by a verbal numeric scale

  • Assess the rate of late complications [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The anaesthesia staff will keep patients under surveillance for potential late complications.


Estimated Enrollment: 1800
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Central venous catheter
All patients who require the placement of a central venous catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405534

Locations
France
Centre Léon Bérard
LYON Cedex 08, France, 69373
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Hervé ROSAY, MD Centre Léon Bérard
  More Information

Publications:
Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01405534     History of Changes
Other Study ID Numbers: VVC
Study First Received: July 28, 2011
Last Updated: May 16, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Leon Berard:
Catheterization, Central Venous

ClinicalTrials.gov processed this record on April 21, 2014