NCT02624323

Brief Summary

The main intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success, early mechanical complication and catheter-related infection rate in mechanically ventilated patients admitted to the intensive care unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

4 years

First QC Date

November 29, 2015

Last Update Submit

August 3, 2020

Conditions

Critical Illness

Keywords

ultrasonographycatheterizationcentral linemechanical ventilationintensive careaxillary veinjugular veinrandomization

Outcome Measures

Primary Outcomes (1)

  • Procedure success rate

    to define catheterization success rate

    24 hours

Secondary Outcomes (3)

  • Incidence of Catheter colonization

    1 month

  • Incidence of catheter-related bloodstream infection

    1 month

  • Procedure complication rate

    24 hours

Study Arms (2)

Axillary catheterization

EXPERIMENTAL

Real-time ultrasound-guided axillary vein catheterization, in plain technique.

Procedure: Real-time ultrasound-guided central vein catheterization.

Jugular catheterization

EXPERIMENTAL

Real-time ultrasound-guided jugular vein catheterization, out of plain technique.

Procedure: Real-time ultrasound-guided central vein catheterization.

Interventions

Real-time ultrasound-guided central vein catheterization.PROCEDURE
Axillary catheterizationJugular catheterization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mechanically ventilated intensive care patients with clinical indications for central venous line placement

You may not qualify if:

  • trauma and hematoma at the catheterization site
  • major blood coagulation disorders coincided with active bleeding
  • anatomical abnormalities at the catheterization site
  • infection at the catheterization site
  • age less than 18 years
  • lack of patients or closest relatives consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Opole, Silesian Voivodeship, 45-401, Poland

Location

2nd Department of Anesthesiology and Critical Care, Medical University of Lublin

Lublin, 20-081, Poland

Location

Related Publications (1)

  • Czarnik T, Czuczwar M, Borys M, Chrzan O, Filipiak K, Maj M, Marszalski M, Miodonska M, Molsa M, Pietka M, Piwoda M, Piwowarczyk P, Rogalska Z, Stachowicz J, Gawda R. Ultrasound-Guided Infraclavicular Axillary Vein Versus Internal Jugular Vein Cannulation in Critically Ill Mechanically Ventilated Patients: A Randomized Trial. Crit Care Med. 2023 Feb 1;51(2):e37-e44. doi: 10.1097/CCM.0000000000005740. Epub 2022 Dec 7.

    PMID: 36476809DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tomasz Czarnik, MD PhD

    Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2015

First Posted

December 8, 2015

Study Start

August 1, 2016

Primary Completion

August 3, 2020

Study Completion

August 3, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations

PL(2)