Clinical trial NCT01405534: Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement
Official title: Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Catheterization, Central Venous
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 1780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patient who require the placement of a central venous catheter

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.


Eligibility 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.

Primary outcomes:
measure: Estimate the acute complications rate
timeFrame: From day 1 to day 7
Secondary outcomes:
measure: Assess the preoperative anxiety
timeFrame: On day 1
measure: Assess patients satisfaction about the catheter
timeFrame: On day 7
measure: Assess postoperative pain
timeFrame: On day 1 and on day 7
measure: Assess the rate of late complications
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: LYON Cedex 08
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Hervé ROSAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.4065/81.9.1159.
citation: 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.
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.
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.
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.