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

Completed

• Conditions: Anesthesia

• Registration Number: NCT01405534
• Lead Sponsor: Centre Leon Berard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Study Start: 2011-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1780

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the acute complications rate	From day 1 to day 7	Placement of the central venous catheter on day 1 and follow-up of potential acute complications

Secondary Outcome Measures

Name	Time	Method
Assess postoperative pain	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
Assess the preoperative anxiety	On day 1	By means of Beck anxiety inventory
Assess patients satisfaction about the catheter	On day 7	By means of a questionnary filled in by patients at home
Assess the rate of late complications	Up to 1 year	The anaesthesia staff will keep patients under surveillance for potential late complications.

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 LYON Cedex 08, France