Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit

NCT ID: NCT02820909

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-03-29

Brief 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.

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.

Conditions

Severely Traumatized Patients in Emergency Wards

Keywords

ultrasound guidance; emergency wards; arterial and venous catheters; femoral; complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Ultrasound guidance

46 patients in the experimental ultrasound group

Group Type: EXPERIMENTAL

venous and arterial catheter set-up using ultrasound guidance

Intervention Type: PROCEDURE

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

46 patients in the anatomical group

Group Type: ACTIVE_COMPARATOR

Anatomical guidance.

Intervention Type: PROCEDURE

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.

Interventions

venous and arterial catheter set-up using ultrasound guidance

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurelie MAZAUD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon

Locations

Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 34503827 (View on PubMed)

Other Identifiers

69HCL16_0403

Identifier Type: -

Identifier Source: org_study_id