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

Not Applicable

Completed

• Conditions: Severely Traumatized Patients in Emergency Wards
• Interventions: Procedure: venous and arterial catheter set-up using ultrasound guidance; Procedure: Anatomical guidance.

• Registration Number: NCT02820909
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-29
• Study Start: 2016-07
• Study First Posted: 2016-07-01
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guidance	venous and arterial catheter set-up using ultrasound guidance	46 patients in the experimental ultrasound group
Anatomical guidance	Anatomical guidance.	46 patients in the anatomical group

Primary Outcome Measures

Name	Time	Method
Proportion of complications 1 week after catheter set-up.	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.

Secondary Outcome Measures

Name	Time	Method
Cannulation time between the 2 groups	the day of surgery (Day 1)	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).
Success of cannulation	the day of intervention (Day 1)	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
Number of cannulation attempt	the day of intervention (Day 1)	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.
Number of puncture attempt	day of intervention (Day 1)	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.
total catheter set-up time between the 2 groups	the day of intervention (Day 1)	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.

Trial Locations

Locations (1)

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