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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01405534
First received: July 28, 2011
Last updated: September 11, 2014
Last verified: September 2014
  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

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.


Enrollment: 1780
Study Start Date: November 2011
Study Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 11, 2014
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 September 18, 2014