Critical IllnessNCT02624323
Ultrasound Guided Axillary Versus Jugular Central Venous Catheterization
A study testing Real-time ultrasound-guided central vein catheterization. in people with Critical Illness, run by Uniwersytecki Szpital Kliniczny w Opolu at 2 sites in Poland.
Trial summary
The main intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success… 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 central vein catheterization.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 2 sitesPoland
- Study dates
- Aug 2016to 3 Aug 2020
- 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 intensive care patients with clinical indications for central venous line placement
Who cannot join
- trauma and hematoma at the catheterization site
- major blood coagulation disorders coincided with active bleeding
- anatomical abnormalities at the catheterization site
- infection at the catheterization site
- age less than 18 years
- lack of patients or closest relatives consent
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
Lublin, 20-081
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, Silesian Voivodeship, 45-401
About this study
Official title: Real-time Ultrasound-guided Axillary and Jugular Vein Catheterization: A Prospective Comparison in Mechanically Ventilated Critically Ill Patients. A Randomized Study
The main intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success, early mechanical complication and catheter-related infection rate in mechanically ventilated patients admitted to the intensive care unit.
- Conditions
- Critical Illness
- Being tested
- Real-time ultrasound-guided central vein catheterization.
- Keywords
- ultrasonography, catheterization, central line, mechanical ventilation, intensive care, axillary vein, jugular vein, randomization
- 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 central vein catheterization.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Axillary catheterization | Experimental | Real-time ultrasound-guided axillary vein catheterization, in plain technique. Receives: Procedure: Real-time ultrasound-guided central vein catheterization. |
| Jugular catheterization | Experimental | Real-time ultrasound-guided jugular vein catheterization, out of plain technique. Receives: Procedure: Real-time ultrasound-guided central vein catheterization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success rate
to define catheterization success rate
Measured: 24 hours
Secondary outcomes (3)
Incidence of Catheter colonization
to assess the incidence of catheter colonization after removal
Measured: 1 month
Incidence of catheter-related bloodstream infection
to assess the incidence of catheter-related bloodstream infection
Measured: 1 month
Procedure complication rate
to assess the early mechanical complication rate
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 posted8 Dec 2015 (estimated)
- Study startAug 2016
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
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
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
- Investigators
- Tomasz Czarnik, MD PhD, Principal investigator, Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624323
- Sponsor's protocol ID
- AxillaryJugularUSG-RCT
- Status last verified
- Aug 2020
- First submitted
- 29 Nov 2015
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Czarnik T, Czuczwar M, Borys M, Chrzan O, Filipiak K, Maj M, Marszalski M, Miodonska M, Molsa M, Pietka M, Piwoda M, Piwowarczyk P, Rogalska Z, Stachowicz J, Gawda R. Ultrasound-Guided Infraclavicular Axillary Vein Versus Internal Jugular Vein Cannulation in Critically Ill Mechanically Ventilated Patients: A Randomized Trial. Crit Care Med. 2023 Feb 1;51(2):e37-e44. doi: 10.1097/CCM.0000000000005740. Epub 2022 Dec 7.
PubMed 36476809
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Ultrasound-guided Axillary and Jugular Vein Catheterization: A Prospective Comparison in Mechanically Ventilated Critically Ill Patients. A Randomized Study
- ClinicalTrials.gov ID
- NCT02624323
- Acronym / sponsor ID
- AxillaryJugularUSG-RCT
- Conditions
- Critical Illness
- Keywords
- ultrasonography, catheterization, central line, mechanical ventilation, intensive care, axillary vein, jugular vein, randomization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 8 Dec 2015 (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 intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success, early mechanical complication and catheter-related infection rate in mechanically ventilated patients admitted to the intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary catheterization | Experimental | Procedure: Real-time ultrasound-guided central vein catheterization.Real-time ultrasound-guided axillary vein catheterization, in plain technique. |
| Jugular catheterization | Experimental | Procedure: Real-time ultrasound-guided central vein catheterization.Real-time ultrasound-guided jugular vein catheterization, out of plain technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanically ventilated intensive care patients with clinical indications for central venous line placement
Key exclusion criteria (6 listed)
- trauma and hematoma at the catheterization site
- major blood coagulation disorders coincided with active bleeding
- anatomical abnormalities at the catheterization site
- infection at the catheterization site
- age less than 18 years
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 central vein catheterization. | Procedure or surgery | Axillary catheterization, Jugular catheterization |
Primary outcome
Procedure success rate
Time frame: 24 hours
to define catheterization success rate
3 secondary outcomes
Incidence of Catheter colonization
Time frame: 1 month
Incidence of catheter-related bloodstream infection
Time frame: 1 month
Procedure complication rate
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 4 Aug 2020.
- Derived from this study: PubMed 36476809Czarnik T, Czuczwar M, Borys M, Chrzan O, Filipiak K, Maj M, Marszalski M, Miodonska M, Molsa M, Pietka M, Piwoda M, Piwowarczyk P, Rogalska Z, Stachowicz J, Gawda R. Ultrasound-Guided Infraclavicular Axillary Vein Versus Internal Jugular Vein Cannulation in Critically Ill Mechanically Ventilated Patients: A Randomized Trial. Crit Care Med. 2023 Feb 1;51(2):e37-e44. doi: 10.1097/CCM.0000000000005740. Epub 2022 Dec 7.
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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.
Tomasz Czarnik, MD PhD principal investigator
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
2 sites 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 central vein catheterization. in people with Critical Illness, run by Uniwersytecki Szpital Kliniczny w Opolu at 2 sites 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 6 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Procedure 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 NCT02624323, 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 4 Aug 2020.