Obesity Clinical Trial
— CATHETEROfficial title:
Impact of Ultrasound Guided Central Venous Catheterization on Complications in Obese Patients in Intensive Care Unit
Verified date | August 2018 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 264 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire d'Amiens | Amiens | Picardie |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of complications | To compare the rate of complications (mechanical, thrombotic and infectious) of CVC posed by US-guided method vs. anatomical method on obese patients in ICU. | Within 4 days following installation of CVC | |
Secondary | The rate of success/failure installation | Failure rate / success when placing CVC. Failure is defined by three skin biopsies that did not lead to the laying of the venous access. | Day 1 | |
Secondary | The time of installation | Time between the first puncture and the correct installation of the catheter | Day 1 | |
Secondary | Number of punctures | The number of punctures required to correctly install the CVC | Day 1 | |
Secondary | Type of complications | Type of complications depending on the method and site installation | Within 4 days following installation of CVC | |
Secondary | Mortality | Within 4 days following installation of CVC | ||
Secondary | The duration of stay | The duration of stay in ICU and in the hospital | Within 4 days following installation of CVC |
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