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Terminated NCT01154465

A Trial to Study the Influence of Ultrasound Guidance on the Complications of Central Catheter

Conditions: Central Venous Catheters, Obesity

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 264
Sponsor: Centre Hospitalier Universitaire, Amiens

Location: Centre Hospitalier Universitaire d'Amiens Amiens Picardie

Summary

Central venous catheterization (CVC) in ICU is very common. It is associated with many complications. These complications are now well identified in the literature. They are primarily mechanical, infectious and thrombotic events. Many measures are taken to reduce them as the choice of insertion site, strict aseptic technique during insertion and type of catheter used. However, despite these measures, it appears that the incidence of these complications is still high. The technique of ultra-sound guided (USG) catheter insertion has shown its effectiveness in reducing complications in the general ICU population. The increase in obesity in the general population is accompanied by an increase in the obese population in the ICU (BMI \> 30 kg.m-2). Many studies have investigated the effect of obesity on morbidity and mortality in ICU. Some studies found a higher rate of catheter infections in obese patient. Moreover, insertion of central venous catheter is technically more difficult in obese patients. To the investigators knowledge there are no studies on the impact of USG central venous catheterization in obese patients in ICU. The objective of this prospective randomized controlled study is to demonstrate the superiority of USG central venous catheterization (jugular or femoral) on complications in a population of obese patients. 450 patients will be included and dispatched in two groups (jugular or femoral) according to the chosen site of catheter insertion. In both groups, patients will be randomized in the USG technique or the usual anatomical technique. The rate of complications (mechanical, thrombotic or infectious) will be the primary endpoint. Secondary endpoints will be the following: rate of catheter colonization, rate of catheter-related bacteremia, rate of failure during insertion, number of punctures, procedure timing and mortality The investigators hope to establish a benefit in the use of USG central venous catheterization in obese ICU patients and thus contribute to improve the quality of care.

Eligibility Criteria

Inclusion Criteria: * Age over 18 years. * BMI ≥ 30 kg/m2. * Patient requiring the installation of a central venous catheter (femoral). * Informed consent signed. Exclusion Criteria: * No particular exclusion criteria

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Source: ClinicalTrials.gov (NCT01154465). StuddyBuddy aggregates publicly available trial information.