Radial Artery Stenosis Following PiCCO Catheter Implementation

Artery Stenosis Clinical Trial

Official title:

Occurrence of Radial Artery Stenosis Following PICCO Catheter Cannulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695407
• Other study ID #: GUMed-Wu-001
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2019

Study information

• Verified date: December 2020
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artery Stenosis
• Constriction, Pathologic

Intervention

Other:
• 3 days cannulation
assessment of artery stenosis after 3 days of artery cannulation
• 5 days cannulation
assessment of artery stenosis after 5 days of artery cannulation

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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