Severely Traumatized Patients in Emergency WardsECHOGUIDENCT02820909
Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit
A study testing venous and arterial catheter set-up using ultrasound guidance and Anatomical guidance. in people with Severely Traumatized Patients in Emergency Wards, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severely Traumatized Patients in Emergency Wards
- What is being tested?
- venous and arterial catheter set-up using ultrasound guidance and Anatomical guidance.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 29 Mar 2018
- 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
- Adult
- Included in intensive care unit for severe trauma
- Need for implementation of femoral arterial and venous catheters in accordance with the practices of the service.
- Agreed to participate
- Affiliation to national security
Who cannot join
- Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
- Local infection
- Hypothermia <32°C
- Need for implementation of arterial catheter only
- Need for implementation of venous catheter only
Trial locations and contacts
1 site in 1 country.
France1 site
Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
Lyon, 69003
About this study
Official title: Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit: A Controlled, Randomized Trial: The ECHOGUIDE Study
The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.
The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.
Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.
- Being tested
- venous and arterial catheter set-up using ultrasound guidance, Anatomical guidance.
- Keywords
- ultrasound guidance, emergency wards, arterial and venous catheters, femoral, complications
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous and arterial catheter set-up using ultrasound guidanceProcedure or surgery
The insertion of the venous and arterial catheter will be done using ultrasound guidance. Vein and artery will be identified in cross section. In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit.
Anatomical guidance.Procedure or surgery
In the anatomical group, catheter will be inserted using, as it is currently done in intensive care unit, anatomic landmarks. If catheterization according to the anatomic method is considered too difficult (> 3 punctures), a conversion to ultrasound guidance will be done.
In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guidance | Experimental | 46 patients in the experimental ultrasound group Receives: Procedure: venous and arterial catheter set-up using ultrasound guidance |
| Anatomical guidance | Active comparator | 46 patients in the anatomical group Receives: Procedure: Anatomical guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complications 1 week after catheter set-up.
The primary end point is the proportion of patients with a complication one week after arterial and venous catheter set-up.
Complications will be defined as follows:
- mechanical immediate complications (hematoma, bleeding, dysfunction or non-function of the catheter, or aberrant course subcutaneous catheter)
- Mechanical complications remote installation catheters (arteriovenous fistula, pseudoaneurysm), thrombotic complications.
Vascular assessment will be conducted by an angiologist, using doppler ultrasound of the femoral vessels. Assessment will be made blind from the use of ultrasound guidance during installation.
Measured: 1 week.
Secondary outcomes (5)
Cannulation time between the 2 groups
Comparison of cannulation mean time between the ultrasound guidance group and anatomical guidance group.
Cannulation time is defined as the time in seconds, from the first contact between the needle and the skin, and when the two guide wires are inserted into the vessels (artery and vein).
Measured: the day of surgery (Day 1)
total catheter set-up time between the 2 groups
Comparison of total catheter set-up mean time between the ultrasound guidance group and anatomical guidance group.
Total exposure time of the catheter is defined as the time, in seconds, from the first contact between the needle and the skin, and when the dressing is applied to both catheters in place and fixed.
Measured: the day of intervention (Day 1)
Success of cannulation
Comparison of cannulation success proportion at first attempt between the 2 groups. Cannulation at first attempt is a success if the needle is inserted at first attempt. A cannulation is defined as successful if the needle is inserted without resistance
Measured: the day of intervention (Day 1)
Number of cannulation attempt
Comparison of the number of attempt before cannulation success in between the 2 groups. Conversion to ultrasound guidance in the anatomical guidance group will be taken into account.
Measured: the day of intervention (Day 1)
Number of puncture attempt
Comparison of the total number of puncture between the 2 groups. A puncture test is defined as the passage of the needle without changing direction or without new movement in depth. Each needle withdrawal, followed by a new movement to deep planes or redirection of the needle is regarded as a new test, with or without skin puncture. The number of tests will be evaluated by an observer.
Measured: day of intervention (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severely Traumatized Patients in Emergency WardsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurelie MAZAUD, MD, Principal investigator, Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820909
- Sponsor's protocol ID
- 69HCL16_0403
- Acronym
- ECHOGUIDE
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lazaar S, Mazaud A, Delsuc C, Durand M, Delwarde B, Debord S, Hengy B, Marcotte G, Floccard B, Dailler F, Chirossel P, Bureau-Du-Colombier P, Berthiller J, Rimmele T. Ultrasound guidance for urgent arterial and venous catheterisation: randomised controlled study. Br J Anaesth. 2021 Dec;127(6):871-878. doi: 10.1016/j.bja.2021.07.023. Epub 2021 Sep 6.
PubMed 34503827
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit: A Controlled, Randomized Trial: The ECHOGUIDE Study
- ClinicalTrials.gov ID
- NCT02820909
- Acronym / sponsor ID
- ECHOGUIDE / 69HCL16_0403
- Keywords
- ultrasound guidance, emergency wards, arterial and venous catheters, femoral, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 1 Jul 2016 (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.
The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.
The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.
Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guidance | Experimental | Procedure: venous and arterial catheter set-up using ultrasound guidance46 patients in the experimental ultrasound group |
| Anatomical guidance | Active comparator | Procedure: Anatomical guidance.46 patients in the anatomical group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult
- Included in intensive care unit for severe trauma
- Need for implementation of femoral arterial and venous catheters in accordance with the practices of the service.
- Agreed to participate
- Affiliation to national security
Key exclusion criteria (5 listed)
- Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
- Local infection
- Hypothermia <32°C
- Need for implementation of arterial catheter only
- Need for implementation of venous catheter only
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 |
|---|---|---|
| venous and arterial catheter set-up using ultrasound guidanceThe insertion of the venous and arterial catheter will be done using ultrasound guidance. Vein and artery will be identified in cross section. In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit. | Procedure or surgery | Ultrasound guidance |
| Anatomical guidance.In the anatomical group, catheter will be inserted using, as it is currently done in intensive care unit, anatomic landmarks. If catheterization according to the anatomic method is considered too difficult (> 3 punctures), a conversion to ultrasound guidance will be done. In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit. | Procedure or surgery | Anatomical guidance |
Primary outcome
Proportion of complications 1 week after catheter set-up.
Time frame: 1 week.
The primary end point is the proportion of patients with a complication one week after arterial and venous catheter set-up. Complications will be defined as follows: * mechanical immediate complications (hematoma, bleeding, dysfunction or non-function of the catheter, or aberrant course subcutaneous catheter) * Mechanical complications remote installation catheters (arteriovenous fistula, pseudoaneurysm), thrombotic complications. Vascular assessment will be conducted by an angiologist, using doppler ultrasound of the femoral vessels. Assessment will be made blind from the use of ultrasound guidance during installation.
5 secondary outcomes
Cannulation time between the 2 groups
Time frame: the day of surgery (Day 1)
total catheter set-up time between the 2 groups
Time frame: the day of intervention (Day 1)
Success of cannulation
Time frame: the day of intervention (Day 1)
Number of cannulation attempt
Time frame: the day of intervention (Day 1)
Number of puncture attempt
Time frame: day of intervention (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 34503827Lazaar S, Mazaud A, Delsuc C, Durand M, Delwarde B, Debord S, Hengy B, Marcotte G, Floccard B, Dailler F, Chirossel P, Bureau-Du-Colombier P, Berthiller J, Rimmele T. Ultrasound guidance for urgent arterial and venous catheterisation: randomised controlled study. Br J Anaesth. 2021 Dec;127(6):871-878. doi: 10.1016/j.bja.2021.07.023. Epub 2021 Sep 6.
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.
Aurelie MAZAUD, MD principal investigator
Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous and arterial catheter set-up using ultrasound guidance and Anatomical guidance. in people with Severely Traumatized Patients in Emergency Wards, run by Hospices Civils de Lyon 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Dec 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of complications 1 week after catheter set-up. (time frame: 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820909, which also lists 1 linked publication.
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 19 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.