Color Doppler and Peripheral Venous Catheters

June 17, 2019 updated by: Efrain Riveros Perez, MD, Augusta University

Utility of Color-flow Doppler to Identify Peripheral Intravenous Catheter Infiltration in Adult Surgical Patients

Objective: To evaluate color Doppler flow ultrasound compared to standard clinical techniques, to detect the correct position of peripheral intravenous catheters in adult surgical patients.

Methods: A prospective study is conducted in adult (>18 years old) patients scheduled to undergo elective surgery. Peripheral intravenous catheter position is evaluated with standard clinical techniques (free flow of fluid from a hanging bag, easy saline injection, and aspiration of blood), and with color flow Doppler ultrasound proximal to the insertion site. Comparative test performance is carried out.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Confirmation of adequate peripheral intravenous catheter placement should be determined before using the parenteral route; however, there is no gold standard universally accepted for this purpose. Determination of the correct position of freshly inserted peripheral intravenous catheters and already established intravenous lines depends largely on subjective clinical signs such as visual evidence of swelling around the insertion site, low resistance to infusion and free back-flow of blood. Ultrasound-guided cannulation of peripheral veins has gained popularity in recent years and is standard of practice in some institutions. Primarily used in guiding central line placement, the applications of ultrasound for vascular access continue to expand in the perioperative setting, thanks to its easy use, non-invasiveness and safety profile. On the other hand, utilization of color Doppler technology with flow injection test has been shown to be a valuable tool for early recognition of malfunctioning intravenous catheters. The color Doppler flow technique is both safe and reliable, and aids in identification of correct intravascular position of venous catheters in children.

This study aims to test the hypothesis that the color Doppler flow technique is superior to standard clinical techniques (free flow from a hanging intravenous fluid bag, aspiration of venous blood with syringe, and non-obstructed hand injection of 2 mL of normal saline) to detect the correct position of peripheral intravenous catheters in adult surgical patients.

Study Type

Observational

Enrollment (Actual)

100

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

    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University

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

Sampling Method

Non-Probability Sample

Study Population

Adults patients with a peripheral venous catheter in situ, scheduled for elective surgery

Description

Inclusion Criteria:

  • Age >18 years undergoing elective surgery with an indwelling peripheral venous catheter.

Exclusion Criteria:

  • Patients with open wounds in the vicinity of the intravenous line insertion site or scar tissue on the extremity, as well as those with dressings, bandages, or casts on the extremity precluding adequate use of ultrasound.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peripheral IV
Patients with peripheral intravenous line in place undergoing elective surgery
Color flow doppler proximal to vein insertion site to document flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravascular catheter position
Time Frame: 2 minutes
Confirmation of adequate position of peripheral vein catheter confirmed by color flow Doppler
2 minutes

Collaborators and Investigators

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

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 (Actual)

March 30, 2019

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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