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NCT Number: NCT01405534

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Léon Bérard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Assess the preoperative anxiety

    Time frame: On day 1

    By means of Beck anxiety inventory

  2. Assess patients satisfaction about the catheter

    Time frame: On day 7

    By means of a questionnary filled in by patients at home

  3. 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

  4. Assess the rate of late complications

    Time frame: Up to 1 year

    The anaesthesia staff will keep patients under surveillance for potential late complications.

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Acronym: VVC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2011
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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