Artery StenosisNCT02695407
Radial Artery Stenosis Following PiCCO Catheter Implementation
A study testing 3 days cannulation and 5 days cannulation in people with Artery Stenosis, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Cardiac output monitoring devices are commonly used in ICU patients. The most precise use direct measurement, which require artery cannulation. The gold standard is Swan-Ganz catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output) is the alternative way of haemodynamic monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artery Stenosis
- What is being tested?
- 3 days cannulation and 5 days cannulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Apr 2019
- 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
- critically ill patients with haemodynamic monitoring required
Who cannot join
- Barbeau test type D in radial artery
- artery inaccessible for cannulation - based on doppler ultrasonography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occurrence of Radial Artery Stenosis Following PICCO Catheter Cannulation
Cardiac output monitoring devices are commonly used in ICU patients. The most precise use direct measurement, which require artery cannulation. The gold standard is Swan-Ganz catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output) is the alternative way of haemodynamic monitoring. This technology is the easy, less invasive and cost-efficient tool for determining the main hemodynamic parameters of critically ill patients. It is based on two physical principles - transpulmonary thermodilution and pulse contour analysis. Both principles allow the calculation of haemodynamic parameters in critically ill patients. PiCCO method requires peripheral artery cannulation.
Cannulation may be followed by artery stenosis.
Read more
Aims of the study are:
- to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO cannula in place.
- whether 5 days cannulation of radial artery with PiCCO catheter is related to more frequent stenosis rate.
An additional assessment:
- to check whether the eventual stenosis is still present after 3, 14 and 30 days after decannulation - assessment depending on patients availability
Read the detailed description
Barbeau test and Doppler - ultrasonography preceded radial artery cannulation. Catheter removal (after 3 or 5 days of cannulation) is followed by Doppler - usg. Usg -Doppler is performed also 3, 14 and 30 days after decannulation - depending on patient being available
- Conditions
- Artery Stenosis
- Being tested
- 3 days cannulation, 5 days cannulation
- Keywords
- artery cannulation, haemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 days cannulationOther
assessment of artery stenosis after 3 days of artery cannulation
5 days cannulationOther
assessment of artery stenosis after 5 days of artery cannulation
| Study group | Role | What they receive |
|---|---|---|
| 3 days cannulation | Experimental | radial artery cannula removed after 3 days Receives: Other: 3 days cannulation |
| 5 days cannulation | Experimental | radial artery cannula removed after 5 days Receives: Other: 5 days cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography
in one group usg, following decannulation will be performed 3 days after cannulation, in the second group - decannulation and usg will be done 5 days after cannulation.
Measured: up to 5 days after cannulation
Secondary outcomes (1)
Number of patients with persistent artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography
usg will be performed 3, 14 and 30 days after decannulation; depending on patients availability
Measured: 3, 14 and 30 days after decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionMar 2019
- Study completionApr 2019
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 Artery StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Wujtewicz, Medical University of Gdansk
- Investigators
- Magdalena Wujtewicz, Principal investigator, Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695407
- Sponsor's protocol ID
- GUMed-Wu-001
- Status last verified
- Dec 2020
- First submitted
- 25 Jan 2016
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Wujtewicz M, Regent B, Marszalek-Ratnicka R, Smugala A, Szurowska E, Owczuk R. The Incidence of Radial Artery Occlusion in Critically Ill Patients after Cannulation with a Long Catheter. J Clin Med. 2021 Jul 19;10(14):3172. doi: 10.3390/jcm10143172.
PubMed 34300338
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Radial Artery Stenosis Following PICCO Catheter Cannulation
- ClinicalTrials.gov ID
- NCT02695407
- Acronym / sponsor ID
- GUMed-Wu-001
- Conditions
- Artery Stenosis
- Keywords
- artery cannulation, haemodynamic monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 1 Mar 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.
Cardiac output monitoring devices are commonly used in ICU patients. The most precise use direct measurement, which require artery cannulation. The gold standard is Swan-Ganz catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output) is the alternative way of haemodynamic monitoring. This technology is the easy, less invasive and cost-efficient tool for determining the main hemodynamic parameters of critically ill patients. It is based on two physical principles - transpulmonary thermodilution and pulse contour analysis. Both principles allow the calculation of haemodynamic parameters in critically ill patients. PiCCO method requires peripheral artery cannulation.
Cannulation may be followed by artery stenosis.
Aims of the study are:
- to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO cannula in place.
- whether 5 days cannulation of radial artery with PiCCO catheter is related to more frequent stenosis rate.
An additional assessment:
- to check whether the eventual stenosis is still present after 3, 14 and 30 days after decannulation - assessment depending on patients availability
Detailed description
Barbeau test and Doppler - ultrasonography preceded radial artery cannulation. Catheter removal (after 3 or 5 days of cannulation) is followed by Doppler - usg. Usg -Doppler is performed also 3, 14 and 30 days after decannulation - depending on patient being available
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 days cannulation | Experimental | Other: 3 days cannulationradial artery cannula removed after 3 days |
| 5 days cannulation | Experimental | Other: 5 days cannulationradial artery cannula removed after 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- critically ill patients with haemodynamic monitoring required
Key exclusion criteria (2 listed)
- Barbeau test type D in radial artery
- artery inaccessible for cannulation - based on doppler ultrasonography
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 |
|---|---|---|
| 3 days cannulationassessment of artery stenosis after 3 days of artery cannulation | Other | 3 days cannulation |
| 5 days cannulationassessment of artery stenosis after 5 days of artery cannulation | Other | 5 days cannulation |
Primary outcome
Number of patients with artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography
Time frame: up to 5 days after cannulation
in one group usg, following decannulation will be performed 3 days after cannulation, in the second group - decannulation and usg will be done 5 days after cannulation.
1 secondary outcome
Number of patients with persistent artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography
Time frame: 3, 14 and 30 days after decannulation
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 8 Dec 2020.
- Derived from this study: PubMed 34300338Wujtewicz M, Regent B, Marszalek-Ratnicka R, Smugala A, Szurowska E, Owczuk R. The Incidence of Radial Artery Occlusion in Critically Ill Patients after Cannulation with a Long Catheter. J Clin Med. 2021 Jul 19;10(14):3172. doi: 10.3390/jcm10143172.
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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.
Magdalena Wujtewicz principal investigator
Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 days cannulation and 5 days cannulation in people with Artery Stenosis, run by Medical University of Gdansk 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 2 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 8 Dec 2020. 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?
Number of patients with artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography (time frame: up to 5 days after cannulation). 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 NCT02695407, 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 8 Dec 2020.