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Completed

NCT Number: NCT02695407

Radial Artery Stenosis Following PiCCO Catheter Implementation

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

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Key information

Conditions

Artery Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Gdansk

Gdansk, 80-214, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 days cannulation

Other

assessment of artery stenosis after 3 days of artery cannulation

5 days cannulation

Other

assessment of artery stenosis after 5 days of artery cannulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of patients with persistent artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography

    Time frame: 3, 14 and 30 days after decannulation

    usg will be performed 3, 14 and 30 days after decannulation; depending on patients availability

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

Occurrence of Radial Artery Stenosis Following PICCO Catheter Cannulation

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2016
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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