Radial Artery Stenosis Following PiCCO Catheter Implementation

December 6, 2020 updated by: Magdalena Wujtewicz, Medical University of Gdansk

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-214
        • Medical University of Gdańsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 3 days cannulation
radial artery cannula removed after 3 days
Other: 3 days cannulation
assessment of artery stenosis after 3 days of artery cannulation
EXPERIMENTAL: 5 days cannulation
radial artery cannula removed after 5 days
Other: 5 days cannulation
assessment of artery stenosis after 5 days of artery cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 days after cannulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 14 and 30 days after decannulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Magdalena Wujtewicz, Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (ESTIMATE)

March 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUMed-Wu-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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