Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.
AxFemArt
A Randomized Study of Ultrasound-guided Axillary and Femoral Artery Cannulation in Mechanically Ventilated Critically Ill Patients.
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedDecember 21, 2021
December 1, 2021
2.7 years
June 7, 2016
December 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cannulation success rate
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.
24 hours
Secondary Outcomes (2)
Procedure complication rate.
24 hours
Number of puncture attempts.
24 hours
Study Arms (2)
Axillary artery.
EXPERIMENTALCannulation of the axillary artery.
Femoral artery.
EXPERIMENTALCannulation of the femoral artery.
Interventions
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401, Poland
Related Publications (1)
Gawda R, Marszalski M, Piwoda M, Molsa M, Pietka M, Filipiak K, Miechowicz I, Czarnik T. Infraclavicular, Ultrasound-Guided Percutaneous Approach to the Axillary Artery for Arterial Catheter Placement: A Randomized Trial. Crit Care Med. 2024 Jan 1;52(1):44-53. doi: 10.1097/CCM.0000000000006015. Epub 2023 Aug 7.
PMID: 37548510DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryszard Gawda, MD PhD
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ryszard Gawda, MD PhD
Study Record Dates
First Submitted
June 7, 2016
First Posted
June 16, 2016
Study Start
January 22, 2018
Primary Completion
October 1, 2020
Study Completion
August 1, 2021
Last Updated
December 21, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share