Critical IllnessAxFemArtNCT02801825
Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.
A study testing Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation. and Real-time ultrasound-guided out-of-plane femoral artery cannulation. in people with Critical Illness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation. and Real-time ultrasound-guided out-of-plane femoral artery cannulation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- 22 Jan 2018to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
About this study
Official title: A Randomized Study of Ultrasound-guided Axillary and Femoral Artery Cannulation in Mechanically Ventilated Critically Ill Patients.
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.
- Conditions
- Critical Illness
- Being tested
- Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation., Real-time ultrasound-guided out-of-plane femoral artery cannulation.
- Keywords
- axillay artery, cannulation, femoral artery
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.Procedure or surgery
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Real-time ultrasound-guided out-of-plane femoral artery cannulation.Procedure or surgery
Real-time ultrasound-guided out-of-plane femoral artery cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Axillary artery. | Experimental | Cannulation of the axillary artery. Receives: Procedure: Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation. |
| Femoral artery. | Experimental | Cannulation of the femoral artery. Receives: Procedure: Real-time ultrasound-guided out-of-plane femoral artery cannulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
Procedure complication rate.
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.
Measured: 24 hours
Number of puncture attempts.
The goal of the assessment is the evaluation which approach is easier to perform.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start22 Jan 2018
- Primary completion1 Oct 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryszard Gawda, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
- Investigators
- Ryszard Gawda, MD PhD, Principal investigator, Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801825
- Sponsor's protocol ID
- AxFemArt
- Acronym
- AxFemArt
- Status last verified
- Dec 2021
- First submitted
- 7 Jun 2016
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37548510
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Ultrasound-guided Axillary and Femoral Artery Cannulation in Mechanically Ventilated Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT02801825
- Acronym / sponsor ID
- AxFemArt / AxFemArt
- Conditions
- Critical Illness
- Keywords
- axillay artery, cannulation, femoral artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary artery. | Experimental | Procedure: Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.Cannulation of the axillary artery. |
| Femoral artery. | Experimental | Procedure: Real-time ultrasound-guided out-of-plane femoral artery cannulation.Cannulation of the femoral artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- in whom radial artery cannulation is unable to perform or
- in order to conduct hemodynamic monitoring using transpulmonary thermodilution
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation. | Procedure or surgery | Axillary artery. |
| Real-time ultrasound-guided out-of-plane femoral artery cannulation.Real-time ultrasound-guided out-of-plane femoral artery cannulation. | Procedure or surgery | Femoral artery. |
Primary outcome
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.
2 secondary outcomes
Procedure complication rate.
Time frame: 24 hours
Number of puncture attempts.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Derived from this study: PubMed 37548510Gawda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryszard Gawda, MD PhD principal investigator
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation. and Real-time ultrasound-guided out-of-plane femoral artery cannulation. in people with Critical Illness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannulation success rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02801825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.