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

Primary Purpose

Severely Traumatized Patients in Emergency Wards

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
venous and arterial catheter set-up using ultrasound guidance
Anatomical guidance.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Severely Traumatized Patients in Emergency Wards focused on measuring ultrasound guidance, emergency wards, arterial and venous catheters, femoral, complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound guidance

Anatomical guidance

Arm Description

46 patients in the experimental ultrasound group

46 patients in the anatomical group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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
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.
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.

Full Information

First Posted
June 29, 2016
Last Updated
September 12, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02820909
Brief Title
Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit
Acronym
ECHOGUIDE
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severely Traumatized Patients in Emergency Wards
Keywords
ultrasound guidance, emergency wards, arterial and venous catheters, femoral, complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guidance
Arm Type
Experimental
Arm Description
46 patients in the experimental ultrasound group
Arm Title
Anatomical guidance
Arm Type
Active Comparator
Arm Description
46 patients in the anatomical group
Intervention Type
Procedure
Intervention Name(s)
venous and arterial catheter set-up using ultrasound guidance
Intervention Description
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
Intervention Name(s)
Anatomical guidance.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of complications 1 week after catheter set-up.
Description
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.
Time Frame
1 week.
Secondary Outcome Measure Information:
Title
Cannulation time between the 2 groups
Description
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).
Time Frame
the day of surgery (Day 1)
Title
total catheter set-up time between the 2 groups
Description
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.
Time Frame
the day of intervention (Day 1)
Title
Success of cannulation
Description
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
Time Frame
the day of intervention (Day 1)
Title
Number of cannulation attempt
Description
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.
Time Frame
the day of intervention (Day 1)
Title
Number of puncture attempt
Description
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.
Time Frame
day of intervention (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelie MAZAUD, MD
Organizational Affiliation
Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34503827
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.
Results Reference
derived

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

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