A Trial to Study the Influence of Ultrasound Guidance on the Complications of Central Catheter - Full Text View

Purpose

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.

Condition	Intervention
Catheterization Obesity	Procedure: Central Venous Catheter Insertion Device: Ultrasound guidance

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Impact of Ultrasound Guided Central Venous Catheterization on Complications in Obese Patients in Intensive Care Unit

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Povidone-iodine

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:

Rate of complications [ Time Frame: Within 4 days following installation of CVC ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

The rate of success/failure installation [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Failure rate / success when placing CVC. Failure is defined by three skin biopsies that did not lead to the laying of the venous access.
The time of installation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Time between the first puncture and the correct installation of the catheter
Number of punctures [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
The number of punctures required to correctly install the CVC
Type of complications [ Time Frame: Within 4 days following installation of CVC ] [ Designated as safety issue: Yes ]
Type of complications depending on the method and site installation
Mortality [ Time Frame: Within 4 days following installation of CVC ] [ Designated as safety issue: Yes ]
The duration of stay [ Time Frame: Within 4 days following installation of CVC ] [ Designated as safety issue: No ]
The duration of stay in ICU and in the hospital

Estimated Enrollment:	450
Study Start Date:	July 2010
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Anatomical guidance puncture 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 or femoral pulse. The puncture will be made following: The anterior Boulanger's incision for the internal jugular vein; 2 cm below and medial to the femoral artery for the femoral incision. When venous aspiration is obtained, the catheter is assembled according to the Seldinger method.	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. Other Names: Betadine Arrow®
Experimental: US-guided puncture 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; 2 cm below and medial to the femoral artery for the femoral pathway. 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.	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. Other Names: Betadine Arrow® 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; 2 cm below and medial to the femoral artery to the femoral incision. 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. Other Name: Site~Rite ® V (C.R. Bard Inc)

Arms

Assigned Interventions

Active Comparator: Anatomical guidance puncture

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 or femoral pulse.

The puncture will be made following:

The anterior Boulanger's incision for the internal jugular vein;
2 cm below and medial to the femoral artery for the femoral incision. When venous aspiration is obtained, the catheter is assembled according to the Seldinger method.

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.

Other Names:

Betadine
Arrow®

Experimental: US-guided puncture

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;
2 cm below and medial to the femoral artery for the femoral pathway. 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.

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.

Other Names:

Betadine
Arrow®

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;
2 cm below and medial to the femoral artery to the femoral incision. 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.

Other Name: Site~Rite ® V (C.R. Bard Inc)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No particular exclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154465

Contacts

Contact: Hervé DUPONT, MD-PhD	+33322668375	dupont.herve@chu-amiens.fr
Contact: Norair AIRAPETIAN, MD	+3332266380	airapetian.norair@chu-amiens.fr

Locations

France
Centre Hospitalier Universitaire d'Amiens	Recruiting
Amiens, Picardie, France, 80000
Contact: Hervé Dupont, MD-PhD +33322668375 dupont.herve@chu-amiens.fr
Contact: Norair Airapetian, MD +3332266380 airapetian.norair@chu-amiens.fr
Principal Investigator: Norair Airapetian, MD
Sub-Investigator: Elie Zogheib, MD
Sub-Investigator: Fanny Delanghe, MD
Sub-Investigator: Santhi Samy Modeliar, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator:	Hervé DUPONT, MD-PhD	Centre Hospitalo-Universitaire d'Amiens
Principal Investigator:	Norair AIRAPETIAN, MD	Centre Hospitalier Universitaire d'Amiens

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT01154465 History of Changes
Other Study ID Numbers:	AOL09-PR-DUPONT, 2009-A01335-52
Study First Received:	June 29, 2010
Last Updated:	September 26, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:

Central venous catheterization
Obese
Ultrasound guidance
Jugular

Femoral
Randomized
Intensive Care Unit

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013