NCT05607238

Brief Summary

This study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 13, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 2, 2023

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 13, 2022

Last Update Submit

May 31, 2023

Conditions

Keywords

IV accessultrasound guided IVemergency care

Outcome Measures

Primary Outcomes (2)

  • Patient Satisfaction with Procedure

    Score describes a patient's satisfaction with a healthcare decision. It measures satisfaction across 6 domains via 6 questions scored on a 5 point scale. Score ranges from 6 to 30. A low score signifies dissatisfaction, a high score signifies high satisfaction.

    Immediately after procedure/Baseline

  • Patient Satisfaction with Procedure

    Score describes a patient's satisfaction with a healthcare decision. It measures satisfaction across 6 domains via 6 questions scored on a 5 point scale. Score ranges from 6 to 30. A low score signifies dissatisfaction, a high score signifies high satisfaction.

    At 48 Hours Post Baseline

Secondary Outcomes (10)

  • Number of needle punctures in a 24 hour period (patient reported)

    up to 48 hours

  • Duration of Successful Access

    up to 48 hours

  • Number of Needle Sticks

    up to 48 hours

  • Number of Insertion Attempts

    up to 48 hours

  • Emergency Department (ED) Length of Stay

    up to 48 hours

  • +5 more secondary outcomes

Study Arms (2)

Ultrasound Guided Peripheral IV

ACTIVE COMPARATOR

Placement of 4-5cm angiocath under ultrasound guidance

Procedure: Ultrasound Guided Vascular Access - peripheral IV

Ultrasound Guided Midline Catheter

EXPERIMENTAL

Placement of 10-15cm midline catheter under ultrasound guidance

Procedure: Ultrasound Guided Vascular Access - Midline catheter

Interventions

Ultrasound guided vascular access with a midline IV catheter

Ultrasound Guided Midline Catheter

Ultrasound guided vascular access with a peripheral IV catheter

Ultrasound Guided Peripheral IV

Eligibility Criteria

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

You may qualify if:

  • Patient in the emergency department
  • Failed 2 or more conventional attempts at vascular access \*or\*
  • history of requiring US guided vascular access
  • US Fellowship trained physician available

You may not qualify if:

  • basilic vein access is contraindicated
  • patient undergoing advanced resuscitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient SatisfactionPatient Preference

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Casey Glass, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

November 7, 2022

Study Start

May 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 2, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share