Central Venous CathetersCATHETERNCT01154465
A Trial to Study the Influence of Ultrasound Guidance on the Complications of Central Catheter
A study testing Central Venous Catheter Insertion and Ultrasound guidance in people with Central Venous Catheters and Obesity, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheters, Obesity
- What is being tested?
- Central Venous Catheter Insertion and Ultrasound guidance
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2010to 26 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- BMI ≥ 30 kg/m2.
- Patient requiring the installation of a central venous catheter (femoral).
- Informed consent signed.
Who cannot join
- No particular exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ultrasound Guided Central Venous Catheterization on Complications in Obese Patients in Intensive Care Unit
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.
Read more
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.
Read the detailed description
Determination of the insertion technique
The insertion technique (with anatomical landmarks or ultrasound-guided) will be determined by randomization. To that aim, we will use a software available on an intranet server and available from all ICUs involved in the study.
All central venous catheters included in the study will be inserted by experienced physicians trained to the use of ultrasound for the placement of access (minimum 2 previous CVC installations with ultrasound).
The central catheters used in the study (Arrow International, Inc.) are single, double or triple lumen (16 and 20 cm in length). The choice will be made by the clinician in patient management. Catheters impregnated with antibiotics or antiseptics are excluded.
The ultrasound used will be a Site~Rite ® V (C.R. Bard Inc) type equipped with a multifrequency probe of 5-10 MHz.
Acts and examinations performed in the protocol:
- Systematic culture of the CVC and achievement of blood cultures in cases of hyperthermia
- Systematic ultrasound examination at D4 to look for thrombosis.
The examinations and the necessary samples required to the strict follow-up of the patients will be made in the ICUs participating in the study and sent to the usual laboratories for analysis. Ultrasounds will be performed by physicians of the departments participating in the study.
The primary endpoint is the rate of complications related to a composite criterion incorporating mechanical, thrombotic and infectious complications.
The secondary endpoints are:
- Rate of failure / success when placing catheters (failure is defined by three skin biopsies which did not lead to the laying of the venous access).
- The time required for the installation of CVC (time between the first puncture and the introduction of the catheter)
- The number of punctures before final laying
- Type of complications according to the method and site of installation
- The overall mortality according to the technique used
- The duration of stay in ICU / hospital
We define complications as follows:
- Mechanical complications:
- Number of failed insertion,
- Number of bleeding which required a compression for more than 30 minutes,
- Number of arterial wound,
- Number of misposition visualized on the radiological picture,
- Rare complications (pneumothorax, hematoma, air embolism).
- Infectious complications (according to the recommendations of the Twelfth Conference of Society Consensus resuscitation French updated in 2002):
- Colonization of the catheter: Positive culture (≥ 1 000 CFU / ml) according to the quantitative method described by Brun-Buisson of the catheter's distal end (4-5 cm) aseptically removed. This technique can diagnose colonization induced not only by subcutaneous infection, but also by intra vascular pathway. However, it does not differentiate the mode of colonization.
- Catheter-related infection:
- In the absence of bacteremia, diagnosis of catheter-related infection will be based on:
- a positive culture (> 1 000 CFU / ml) and total or partial regression of signs of infection within 48 hours after catheter removal or
- purulence of the inlet of the catheter or
- tunnelite.
- Bacteremic infection related to the C.V.C. will be defined by:
- the association of one positive bacteremia occurring within 48 hours before or after the withdrawal of CVC (two in case of Staphylococcus epidermidis) and a positive culture of the insertion site by the same organism or a culture of CVC > 1 000 CFU / ml of the same organism or
- a quantitative central / peripheral blood cultures ratio > 5 or
- a differential blood culture positivity delay > 2 hours.
- The infection is NOT related to CVC if :
- the CVC is finally sterile or
- the CVC culture is positive, but the strain is different from that isolated in the blood and / or other focus of infection present at the removal of the CVC and sepsis does not regress to the removal of the CVC or
- the CVC culture is positive and the strain is identical with that found in other infected site found at least 48 hours before removal of the CVC whether or not responsible for bacteremia and sepsis does not regress after the removal of the CVC.
- Thrombotic complications:
A venous Echo-Doppler exploration is performed within four days following the catheter ablation to look for a loss of compressibility of a venous segment under the pressure of the probe associated to an intravascular image measuring more than 3 mm in the anteroposterior diameter (maximum diameter).
- Conditions
- Central Venous Catheters, Obesity
- Being tested
- Central Venous Catheter Insertion, Ultrasound guidance
- Keywords
- Central venous catheterization, Obese, Ultrasound guidance, Jugular, Randomized, Intensive Care Unit
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Venous Catheter InsertionProcedure or surgery
Also called Betadine, Arrow®
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.
Ultrasound guidanceDevice
Also called Site~Rite ® V (C.R. Bard Inc)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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; Receives: Procedure: Central Venous Catheter Insertion; Device: Ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4 days following installation of CVC
Secondary outcomes (6)
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.
Measured: Day 1
The time of installation
Time between the first puncture and the correct installation of the catheter
Measured: Day 1
Number of punctures
The number of punctures required to correctly install the CVC
Measured: Day 1
Type of complications
Type of complications depending on the method and site installation
Measured: Within 4 days following installation of CVC
Mortality
Measured: Within 4 days following installation of CVC
The duration of stay
The duration of stay in ICU and in the hospital
Measured: Within 4 days following installation of CVC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study start26 May 2010
- Primary completion26 May 2017
- Study completion26 May 2017
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé DUPONT, MD-PhD, Principal investigator, Centre Hospitalo-Universitaire d'AmiensNorair AIRAPETIAN, MD, Principal investigator, Centre Hospitalier Universitaire, Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154465
- Sponsor's protocol ID
- AOL09-PR-DUPONT
- Other IDs
- 2009-A01335-52
- Acronym
- CATHETER
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2010
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound Guided Central Venous Catheterization on Complications in Obese Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01154465
- Acronym / sponsor ID
- CATHETER / AOL09-PR-DUPONT
- Conditions
- Central Venous Catheters, Obesity
- Keywords
- Central venous catheterization, Obese, Ultrasound guidance, Jugular, Randomized, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 May 2010 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Determination of the insertion technique
The insertion technique (with anatomical landmarks or ultrasound-guided) will be determined by randomization. To that aim, we will use a software available on an intranet server and available from all ICUs involved in the study.
All central venous catheters included in the study will be inserted by experienced physicians trained to the use of ultrasound for the placement of access (minimum 2 previous CVC installations with ultrasound).
The central catheters used in the study (Arrow International, Inc.) are single, double or triple lumen (16 and 20 cm in length). The choice will be made by the clinician in patient management. Catheters impregnated with antibiotics or antiseptics are excluded.
The ultrasound used will be a Site~Rite ® V (C.R. Bard Inc) type equipped with a multifrequency probe of 5-10 MHz.
Acts and examinations performed in the protocol:
- Systematic culture of the CVC and achievement of blood cultures in cases of hyperthermia
- Systematic ultrasound examination at D4 to look for thrombosis.
The examinations and the necessary samples required to the strict follow-up of the patients will be made in the ICUs participating in the study and sent to the usual laboratories for analysis. Ultrasounds will be performed by physicians of the departments participating in the study.
The primary endpoint is the rate of complications related to a composite criterion incorporating mechanical, thrombotic and infectious complications.
The secondary endpoints are:
- Rate of failure / success when placing catheters (failure is defined by three skin biopsies which did not lead to the laying of the venous access).
- The time required for the installation of CVC (time between the first puncture and the introduction of the catheter)
- The number of punctures before final laying
- Type of complications according to the method and site of installation
- The overall mortality according to the technique used
- The duration of stay in ICU / hospital
We define complications as follows:
- Mechanical complications:
- Number of failed insertion,
- Number of bleeding which required a compression for more than 30 minutes,
- Number of arterial wound,
- Number of misposition visualized on the radiological picture,
- Rare complications (pneumothorax, hematoma, air embolism).
- Infectious complications (according to the recommendations of the Twelfth Conference of Society Consensus resuscitation French updated in 2002):
- Colonization of the catheter: Positive culture (≥ 1 000 CFU / ml) according to the quantitative method described by Brun-Buisson of the catheter's distal end (4-5 cm) aseptically removed. This technique can diagnose colonization induced not only by subcutaneous infection, but also by intra vascular pathway. However, it does not differentiate the mode of colonization.
- Catheter-related infection:
- In the absence of bacteremia, diagnosis of catheter-related infection will be based on:
- a positive culture (> 1 000 CFU / ml) and total or partial regression of signs of infection within 48 hours after catheter removal or
- purulence of the inlet of the catheter or
- tunnelite.
- Bacteremic infection related to the C.V.C. will be defined by:
- the association of one positive bacteremia occurring within 48 hours before or after the withdrawal of CVC (two in case of Staphylococcus epidermidis) and a positive culture of the insertion site by the same organism or a culture of CVC > 1 000 CFU / ml of the same organism or
- a quantitative central / peripheral blood cultures ratio > 5 or
- a differential blood culture positivity delay > 2 hours.
- The infection is NOT related to CVC if :
- the CVC is finally sterile or
- the CVC culture is positive, but the strain is different from that isolated in the blood and / or other focus of infection present at the removal of the CVC and sepsis does not regress to the removal of the CVC or
- the CVC culture is positive and the strain is identical with that found in other infected site found at least 48 hours before removal of the CVC whether or not responsible for bacteremia and sepsis does not regress after the removal of the CVC.
- Thrombotic complications:
A venous Echo-Doppler exploration is performed within four days following the catheter ablation to look for a loss of compressibility of a venous segment under the pressure of the probe associated to an intravascular image measuring more than 3 mm in the anteroposterior diameter (maximum diameter).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomical guidance puncture | Active comparator | Procedure: Central Venous Catheter InsertionThe 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. |
| US-guided puncture | Experimental | Procedure: Central Venous Catheter Insertion, Device: Ultrasound guidanceThe 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; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years.
- BMI ≥ 30 kg/m2.
- Patient requiring the installation of a central venous catheter (femoral).
- Informed consent signed.
Key exclusion criteria (1 listed)
- No particular exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Venous Catheter InsertionAlso: Betadine, Arrow®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. | Procedure or surgery | Anatomical guidance puncture, US-guided puncture |
| Ultrasound guidanceAlso: Site~Rite ® V (C.R. Bard Inc)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. | Device | US-guided puncture |
Primary outcome
Rate of complications
Time frame: Within 4 days following installation of CVC
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.
6 secondary outcomes
The rate of success/failure installation
Time frame: Day 1
The time of installation
Time frame: Day 1
Number of punctures
Time frame: Day 1
Type of complications
Time frame: Within 4 days following installation of CVC
Mortality
Time frame: Within 4 days following installation of CVC
The duration of stay
Time frame: Within 4 days following installation of CVC
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé DUPONT, MD-PhD principal investigator
Centre Hospitalo-Universitaire d'Amiens
Norair AIRAPETIAN, MD principal investigator
Centre Hospitalier Universitaire, Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central Venous Catheter Insertion and Ultrasound guidance in people with Central Venous Catheters and Obesity, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complications (time frame: Within 4 days following installation of CVC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.