Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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.

Estimated Enrollment:	1800
Study Start Date:	November 2011
Estimated Study Completion Date:	June 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

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:

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.

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.

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.

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. Epub 2010 Nov 24.

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.

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.

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:	May 16, 2013
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 June 17, 2013

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