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Radial Artery Stenosis Following PiCCO Catheter Implementation

NCT ID: NCT02695407

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-04-30

Brief Summary

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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:

1. to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO cannula in place.
2. whether 5 days cannulation of radial artery with PiCCO catheter is related to more frequent stenosis rate.

An additional assessment:

1\. to check whether the eventual stenosis is still present after 3, 14 and 30 days after decannulation - assessment depending on patients availability

Detailed Description

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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

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Artery Stenosis

Keywords

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artery cannulation haemodynamic monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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3 days cannulation

radial artery cannula removed after 3 days

Group Type EXPERIMENTAL

3 days cannulation

Intervention Type OTHER

assessment of artery stenosis after 3 days of artery cannulation

5 days cannulation

radial artery cannula removed after 5 days

Group Type EXPERIMENTAL

5 days cannulation

Intervention Type OTHER

assessment of artery stenosis after 5 days of artery cannulation

Interventions

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3 days cannulation

assessment of artery stenosis after 3 days of artery cannulation

Intervention Type OTHER

5 days cannulation

assessment of artery stenosis after 5 days of artery cannulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* critically ill patients with haemodynamic monitoring required

Exclusion Criteria

* Barbeau test type D in radial artery
* artery inaccessible for cannulation - based on doppler ultrasonography
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Wujtewicz

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena Wujtewicz

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland

Locations

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Medical University of Gdansk

Gdansk, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 34300338 (View on PubMed)

Other Identifiers

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GUMed-Wu-001

Identifier Type: -

Identifier Source: org_study_id