- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889678
Color Doppler and Peripheral Venous Catheters
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Augusta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1237593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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