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

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.

Conditions

• Central Venous Catheters
• Obesity

Interventions

PROCEDURE

Central Venous Catheter Insertion

The preparation of the CVC installation will follow the procedures for skin preparation of the operator, installation of sterile fields and local anaesthesia. The patients' skin disinfection before catheter insertion and care will follow the protocol: * Clean the area of insertion of the catheter with a solution of 4% aqueous povidone foaming (Betadine Scrub). * Rinse with sterile water and then drying. * First application of 5% alcohol povidone-iodine (alcoholic Betadine) far beyond the area of insertion. * Second application of 5% alcoholic povidone-iodine (alcoholic Betadine) by the operator after sterile draping. After sterilisation and puncture, the Seldinger technique is employed to insert the line: a blunt guidewire is passed through the needle, and the needle is then removed.

DEVICE

Ultrasound guidance

The ultrasound probe will be isolated by a sterile protective plastic and the operator will mount a ramp on which the puncture syringe needle is placed. A sterile gel will be used in order to visualize the vein and directly puncture under ultrasound guidance following: \- The anterior Boulanger's incision for the internal jugular vein When venous aspiration is obtained, the needle can easily be removed from the ramp and the syringe to mount the catheter following Seldinger's method.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Principal Investigators

• Hervé DUPONT, MD-PhD · Centre Hospitalo-Universitaire d'Amiens

• Norair AIRAPETIAN, MD · Centre Hospitalier Universitaire, Amiens

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-26

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• France

Study Locations