Critical IllnessNCT02083458
An Infraclavicular Landmark-based Approach to the Axillary Vein
A study testing Catheterization of the axillary vein. in people with Critical Illness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
Trial summary
The central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring. 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?
- Catheterization of the axillary vein.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2010to Feb 2014
- 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
- patients admitted to the intensive care unit with indications for central venous catheterization
Who cannot join
- chest wall deformities at the cannulations side
- major hemostasis disorders
- infections at the catheterization site
- age less than 18 years
- lack of patients consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne
Opole, Opole Voivodeship, 45-418
About this study
Official title: A New Infraclavicular Landmark-based Approach to the Axillary Vein as an Alternative Method of Central Venous Cannulation
The central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring.
The procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava.
Read more
There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique.
The primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in patients admitted to the intensive care unit.
- Conditions
- Critical Illness
- Being tested
- Catheterization of the axillary vein.
- Keywords
- critical care, catheterization, axillary vein
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterization of the axillary vein.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| axillary vein catheterization | Experimental | Catheterization of the axillary vein based on anatomical landmark. Receives: Procedure: Catheterization of the axillary vein. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful catheterizations.
Measured: 24 hours
Procedure success rate depending on physician experience.
Measured: 24 hours
Secondary outcomes (1)
Rate of early complications.
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 posted11 Mar 2014 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 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, Uniwersytecki Szpital Kliniczny w Opolu
- Investigators
- Ryszard Gawda, MD, Principal investigator, Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083458
- Sponsor's protocol ID
- Axillary vein - WCM
- Status last verified
- Jun 2016
- First submitted
- 4 Mar 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Infraclavicular Landmark-based Approach to the Axillary Vein as an Alternative Method of Central Venous Cannulation
- ClinicalTrials.gov ID
- NCT02083458
- Acronym / sponsor ID
- Axillary vein - WCM
- Conditions
- Critical Illness
- Keywords
- critical care, catheterization, axillary vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Mar 2014 (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 central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring.
The procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava.
There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique.
The primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in patients admitted to the intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| axillary vein catheterization | Experimental | Procedure: Catheterization of the axillary vein.Catheterization of the axillary vein based on anatomical landmark. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to the intensive care unit with indications for central venous catheterization
Key exclusion criteria (5 listed)
- chest wall deformities at the cannulations side
- major hemostasis disorders
- infections at the catheterization site
- age less than 18 years
- lack of patients consent
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 |
|---|---|---|
| Catheterization of the axillary vein. | Procedure or surgery | axillary vein catheterization |
Primary outcome
Rate of successful catheterizations.
Time frame: 24 hours
Procedure success rate depending on physician experience.
Time frame: 24 hours
1 secondary outcome
Rate of early complications.
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 14 Jun 2016.
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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 principal investigator
Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne 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 Catheterization of the axillary vein. 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 1 inclusion and 5 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 14 Jun 2016. 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?
Rate of successful catheterizations. (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2016.