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Radial Artery Stenosis Following PiCCO Catheter Implementation

Primary Purpose

Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
3 days cannulation
5 days cannulation
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Artery Stenosis focused on measuring artery cannulation, haemodynamic monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Gdansk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3 days cannulation

5 days cannulation

Arm Description

radial artery cannula removed after 3 days

radial artery cannula removed after 5 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 25, 2016
Last Updated
December 6, 2020
Sponsor
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT02695407
Brief Title
Radial Artery Stenosis Following PiCCO Catheter Implementation
Official Title
Occurrence of Radial Artery Stenosis Following PICCO Catheter Cannulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO cannula in place. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artery Stenosis
Keywords
artery cannulation, haemodynamic monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 days cannulation
Arm Type
Experimental
Arm Description
radial artery cannula removed after 3 days
Arm Title
5 days cannulation
Arm Type
Experimental
Arm Description
radial artery cannula removed after 5 days
Intervention Type
Other
Intervention Name(s)
3 days cannulation
Intervention Description
assessment of artery stenosis after 3 days of artery cannulation
Intervention Type
Other
Intervention Name(s)
5 days cannulation
Intervention Description
assessment of artery stenosis after 5 days of artery cannulation
Primary Outcome Measure Information:
Title
Number of patients with artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography
Description
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.
Time Frame
up to 5 days after cannulation
Secondary Outcome Measure Information:
Title
Number of patients with persistent artery stenosis after radial artery decannulation, confirmed by Doppler ultrasonography
Description
usg will be performed 3, 14 and 30 days after decannulation; depending on patients availability
Time Frame
3, 14 and 30 days after decannulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Wujtewicz
Organizational Affiliation
Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34300338
Citation
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.
Results Reference
derived

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Radial Artery Stenosis Following PiCCO Catheter Implementation

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