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

Anesthesia Clinical Trial

— VVC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405534
• Other study ID #: VVC
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: September 11, 2014
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1780
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
France	Centre Léon Bérard	LYON Cedex 08

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Gambotti L, Pérol 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess the preoperative anxiety	By means of Beck anxiety inventory	On day 1	No
Secondary	Assess patients satisfaction about the catheter	By means of a questionnary filled in by patients at home	On day 7	No
Secondary	Assess postoperative pain	The pain will be assessed on day 1 by a visual analogic scale and on day 7 by a verbal numeric scale	On day 1 and on day 7	No
Secondary	Assess the rate of late complications	The anaesthesia staff will keep patients under surveillance for potential late complications.	Up to 1 year	No