NCT02083458

Brief Summary

The central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring. The procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava. There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique. The primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in 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
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

March 4, 2014

Last Update Submit

June 13, 2016

Conditions

Keywords

critical carecatheterizationaxillary vein

Outcome Measures

Primary Outcomes (2)

  • Rate of successful catheterizations.

    24 hours

  • Procedure success rate depending on physician experience.

    24 hours

Secondary Outcomes (1)

  • Rate of early complications.

    24 hours

Study Arms (1)

axillary vein catheterization

EXPERIMENTAL

Catheterization of the axillary vein based on anatomical landmark.

Procedure: Catheterization of the axillary vein.

Interventions

axillary vein catheterization

Eligibility Criteria

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

You may qualify if:

  • patients admitted to the intensive care unit with indications for central venous catheterization

You may not qualify if:

  • chest wall deformities at the cannulations side
  • major hemostasis disorders
  • infections at the catheterization site
  • age less than 18 years
  • lack of patients consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne

Opole, Opole Voivodeship, 45-418, Poland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ryszard Gawda, MD

    Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior anesthesiologist

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

February 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2014

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations