The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter

March 15, 2016 updated by: Soroka University Medical Center

The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter and for the Detection of Complications

Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

The study population will be screened at the internal wards and medical intensive care unit of Soroka Medical Center.

Research candidates' files will be screened routinely by a study coordinator. The study population will be enrolled according to the inclusion and exclusion criteria.

The primary objective for the study is to evaluate whether the use of POCUS in CVC insertion can help inaccurate CVC tip placement, detect misplacement and complications and better than chest X ray.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Soroka University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients admitted to internal ward or medical intensive care unit
  2. Patients in need for central venous catheter in the subclavian or internal jugular veins

Exclusion Criteria:

  1. Subject currently enrolled in another investigational study
  2. Surgical patients with open abdomen covered with bogota bag or vac - pac
  3. Patients with pneumothorax prior to central venous catheter insertion
  4. Patients in need for central venous catheter for hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Prospective implantation of POC US for CVC tip placement.
Device: POC US
Use of point of care ultrasound in insertion of CVC
No Intervention: Control
Retrospective data collection for CVC placement in the medical and surgical ICUs, before the initiation of the study and without the use of POCUS for CVC tip placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of misplacement of the tip of CVC.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of ventricular arrhythmia during line insertion while using POC US
Time Frame: 6 months
6 months
Duration time of CVC insertion using POC US
Time Frame: 6 months
6 months
Number of CVC insertion complications using POC US
Time Frame: 6 months
6 months
Sensitivity (score-the device's ability to identify a condition correctly) of POC US in detection of CVC insertion complications
Time Frame: 6 months
6 months
Specificity (score-the device's ability to exclude a condition correctly) of POC US in detection of CVC insertion complications
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SOR-0131-15-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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