NCT03889678

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

March 22, 2019

Last Update Submit

June 17, 2019

Conditions

Keywords

Color flow Dopplerinfiltrationextravasationperipheral intravenous cathetersgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Intravascular catheter position

    Confirmation of adequate position of peripheral vein catheter confirmed by color flow Doppler

    2 minutes

Study Arms (1)

Peripheral IV

Patients with peripheral intravenous line in place undergoing elective surgery

Diagnostic Test: Color flow doppler

Interventions

Color flow dopplerDIAGNOSTIC_TEST

Color flow doppler proximal to vein insertion site to document flow

Peripheral IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Interventions

Echocardiography, Doppler, Color

Intervention Hierarchy (Ancestors)

Echocardiography, DopplerEchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyUltrasonography, DopplerUltrasonography, Doppler, ColorUltrasonography, Doppler, DuplexHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 26, 2019

Study Start

March 30, 2019

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations