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

NCT01405534 | Completed

• 1 other identifier: VVC
• Study Type: observational
• Target: 1,780
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Catheterization, Central Venous

Outcome Measures

Primary Outcomes (1)

• Estimate the acute complications rate

  Placement of the central venous catheter on day 1 and follow-up of potential acute complications

  From day 1 to day 7

Secondary Outcomes (4)

• Assess the preoperative anxiety

  On day 1

• Assess patients satisfaction about the catheter

  On day 7

• Assess postoperative pain

  On day 1 and on day 7

• Assess the rate of late complications

  Up to 1 year

Study Arms (1)

Central venous catheter

All patients who require the placement of a central venous catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

Related Publications (6)

• Gambotti L, Perol D, Frering B, Kaemmerlen P, Coronel B, Sebban H, Bulso V, Bachelot V, Chauvin F, Bachmann P. Safety of percutaneous internal jugular catheterization in cancer patients: prospective observational study. J Vasc Access. 2004 Oct-Dec;5(4):161-7. doi: 10.1177/112972980400500405.

  PMID: 16596560 BACKGROUND

• Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159.

  PMID: 16970212 BACKGROUND

• Burns KE, McLaren A. Catheter-related right atrial thrombus and pulmonary embolism: a case report and systematic review of the literature. Can Respir J. 2009 Sep-Oct;16(5):163-5. doi: 10.1155/2009/751507.

  PMID: 19851535 BACKGROUND

• Kim HJ, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Park HS, Hong DS. Safety and effectiveness of central venous catheterization in patients with cancer: prospective observational study. J Korean Med Sci. 2010 Dec;25(12):1748-53. doi: 10.3346/jkms.2010.25.12.1748. Epub 2010 Nov 24.

  PMID: 21165289 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.

  PMID: 21368740 BACKGROUND

• Yacopetti N, Alexandrou E, Spencer TR, Frost SA, Davidson PM, O'Sullivan G, Hillman KM. Central venous catheter insertion by a clinical nurse consultant or anaesthetic medical staff: a single-centre observational study. Crit Care Resusc. 2010 Jun;12(2):90-5.

  PMID: 20513216 BACKGROUND

Study Officials

• Hervé ROSAY, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

FR (1)