Radial Artery Stenosis Following PiCCO Catheter Implementation

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: Artery Stenosis
• Intervention / Treatment: Other: 3 days cannulation; Other: 5 days cannulation

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

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

Publications and helpful links

General 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.

Study record dates

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: haemodynamic monitoring; artery cannulation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: GUMed-Wu-001