Patient Perspective Midline Catheter in the Emergency Department

Patient Perspective of Midline Catheters Versus Ultrasound Guided Peripheral IVs for Difficult IV Access in the ED

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

Study Overview

• Status: Withdrawn
• Conditions: Patient Satisfaction; Patient Preference
• Intervention / Treatment: Procedure: Ultrasound Guided Vascular Access - peripheral IV; Procedure: Ultrasound Guided Vascular Access - Midline catheter

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• basilic vein access is contraindicated
• patient undergoing advanced resuscitation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound Guided Peripheral IV; Placement of 4-5cm angiocath under ultrasound guidance	Procedure: Ultrasound Guided Vascular Access - peripheral IV; Ultrasound guided vascular access with a peripheral IV catheter
Experimental: Ultrasound Guided Midline Catheter; Placement of 10-15cm midline catheter under ultrasound guidance	Procedure: Ultrasound Guided Vascular Access - Midline catheter; Ultrasound guided vascular access with a midline IV catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of needle punctures in a 24 hour period (patient reported)		up to 48 hours
Duration of Successful Access	IV/Cath dwell time in hours	up to 48 hours
Number of Needle Sticks	Prior to gaining successful access	up to 48 hours
Number of Insertion Attempts	For ultrasound guided access	up to 48 hours
Emergency Department (ED) Length of Stay	in hours	up to 48 hours
Hospital Length of Stay	in hours	up to 48 hours
Patient Satisfaction	this is a single question measuring satisfaction with the intervention overall on a Likert Scale 1-10,	immediately post intervention/baseline and at 48 hours past baseline
Number of Insertion Related Complications	Includes failed attempts, arterial punctures, infiltrations, hematoma formations	up to 48 hours
Number of Dwell Related Complications	Includes inability to flush, catheter dislodgement, leakage around the catheter site, insertion site erythema, insertion site pain, drainage from catheter, edema, ecchymosis, superficial thrombosis, Deep vein thrombosis (DVT), line associated infection, vesicant extravasation, skin necrosis, neurovascular injury, arterial injury	up to 48 hours
Time to Access	minutes from procedure start to procedure completion	up to 24 hours

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Casey Glass, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: emergency care; IV access; ultrasound guided IV
• Other Study ID Numbers: IRB00089914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No