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Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation. (AxFemArt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801825
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ryszard Gawda, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

Brief Summary:
The main purpose of the study is to compare two ultrasound-guided arterial cannulation procedures: in-plane infraclavicular axillary artery cannulation and out-of-plane femoral artery cannulation.

Condition or disease Intervention/treatment Phase
Critical Illness Procedure: Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation. Procedure: Real-time ultrasound-guided out-of-plane femoral artery cannulation. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Study of Ultrasound-guided Axillary and Femoral Artery Cannulation in Mechanically Ventilated Critically Ill Patients.
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Axillary artery.
Cannulation of the axillary artery.
Procedure: Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.

Experimental: Femoral artery.
Cannulation of the femoral artery.
Procedure: Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Real-time ultrasound-guided out-of-plane femoral artery cannulation.




Primary Outcome Measures :
  1. Cannulation success rate [ Time Frame: 24 hours ]
    The goal of the assessment of the cannulation success rate is essential for the estimation of the usefulness of both artery approaches in clinical practice.


Secondary Outcome Measures :
  1. Procedure complication rate. [ Time Frame: 24 hours ]
    The goal of the assessment of the early mechanical complication rate is crucial for the estimation of the safety of both procedures in clinical practice.

  2. Number of puncture attempts. [ Time Frame: 24 hours ]
    The goal of the assessment is the evaluation which approach is easier to perform.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

mechanically ventilated critically ill patients with indications for artery cannulation:

  • in whom radial artery cannulation is unable to perform or
  • in order to conduct hemodynamic monitoring using transpulmonary thermodilution

Exclusion Criteria:

  • age less than 18 years
  • trauma and hematoma at the catheterization site
  • clinically significant coagulation disorders
  • infection at the catheterization site
  • lack of patients or closest relatives contents
  • precedent surgery operation into the femoral and axillary arteries
  • clinically significant ischemia of the limb at the cannulation side

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801825


Contacts
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Contact: Ryszard Gawda, MD PhD 0048505088794 onetime@wp.pl

Locations
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Poland
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu Recruiting
Opole, Poland, 45-401
Principal Investigator: Ryszard Gawda, MD PhD         
Sub-Investigator: Tomasz Czarnik, MD PhD         
Sponsors and Collaborators
Uniwersytecki Szpital Kliniczny w Opolu
Investigators
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Principal Investigator: Ryszard Gawda, MD PhD Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
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Responsible Party: Ryszard Gawda, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
ClinicalTrials.gov Identifier: NCT02801825    
Other Study ID Numbers: AxFemArt
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryszard Gawda, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu:
axillay artery
cannulation
femoral artery
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes