Clinical trial NCT02820909: Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severely Traumatized Patients in Emergency Wards
Keywords: ultrasound guidance
emergency wards
arterial and venous catheters
femoral
complications
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Proportion of complications 1 week after catheter set-up.
timeFrame: 1 week.
Secondary outcomes:
measure: Cannulation time between the 2 groups
timeFrame: the day of surgery (Day 1)
measure: total catheter set-up time between the 2 groups
timeFrame: the day of intervention (Day 1)
measure: Success of cannulation
timeFrame: the day of intervention (Day 1)
measure: Number of cannulation attempt
timeFrame: the day of intervention (Day 1)
measure: Number of puncture attempt
timeFrame: day of intervention (Day 1)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
Study officials:
affiliation: Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon
name: Aurelie MAZAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.