Radial Artery Stenosis Following PiCCO Catheter Implementation

NCT02695407 | Completed

• 1 other identifier: GUMed-Wu-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Artery Stenosis

Keywords

artery cannulation; haemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3, 14 and 30 days after decannulation

Study Arms (2)

3 days cannulation

EXPERIMENTAL

radial artery cannula removed after 3 days

Other: 3 days cannulation

5 days cannulation

EXPERIMENTAL

radial artery cannula removed after 5 days

Other: 5 days cannulation

Interventions

3 days cannulation OTHER

assessment of artery stenosis after 3 days of artery cannulation

3 days cannulation

5 days cannulation OTHER

assessment of artery stenosis after 5 days of artery cannulation

5 days cannulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• critically ill patients with haemodynamic monitoring required

You may not qualify if:

• Barbeau test type D in radial artery
• artery inaccessible for cannulation - based on doppler ultrasonography

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-214, Poland

Location

Related Publications (1)

• 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.

  PMID: 34300338 DERIVED

MeSH Terms

Interventions

Catheterization

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Magdalena Wujtewicz

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: March 1, 2016
• Study Start: September 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

PL (1)