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

NCT01154465 | Unknown

• 2 other identifiers: AOL09-PR-DUPONT2009-A01335-52
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Central venous catheterization; Obese; Ultrasound guidance; Jugular; Randomized; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The rate of success/failure installation

  Day 1

• The time of installation

  Day 1

• Number of punctures

  Day 1

• Type of complications

  Within 4 days following installation of CVC

• Mortality

  Within 4 days following installation of CVC

Study Arms (2)

Anatomical guidance puncture

ACTIVE COMPARATOR

The patient is placed supine (with a slight neck extension for jugular punctures). The preparation of the CVC installation will follow the procedures for disinfection, for skin preparation of the operator, for installation of sterile fields and for local anaesthesia. The veins will be tracked by simple palpation of the carotid pulse. The puncture will be made following: * The anterior Boulanger's incision for the internal jugular vein; * When venous aspiration is obtained, the catheter is assembled according to the Seldinger method.

Procedure: Central Venous Catheter Insertion

US-guided puncture

EXPERIMENTAL

The patient is placed supine (with a slight neck extension for jugular punctures). 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 pathway;

Procedure: Central Venous Catheter Insertion; Device: Ultrasound guidance

Interventions

Central Venous Catheter Insertion PROCEDURE

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.

Also known as: Betadine, Arrow®

Anatomical guidance puncture; US-guided puncture

Ultrasound guidance DEVICE

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.

Also known as: Site~Rite ® V (C.R. Bard Inc)

US-guided puncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years.
• BMI ≥ 30 kg/m2.
• Patient requiring the installation of a central venous catheter (femoral).
• Informed consent signed.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Hervé DUPONT, MD-PhD

  Centre Hospitalo-Universitaire d'Amiens

  PRINCIPAL INVESTIGATOR

• Norair AIRAPETIAN, MD

  Centre Hospitalier Universitaire, Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: May 26, 2011
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)