Patient Perspective Midline Catheter in the Emergency Department

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05607238

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction Patient Preference	Procedure: Ultrasound Guided Vascular Access - Midline catheter Procedure: Ultrasound Guided Vascular Access - peripheral IV	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient Satisfaction with Procedure [Immediately after procedure/Baseline]
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.
Patient Satisfaction with Procedure [At 48 Hours Post Baseline]
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.

Secondary Outcome Measures

Number of needle punctures in a 24 hour period (patient reported) [up to 48 hours]
Duration of Successful Access [up to 48 hours]
IV/Cath dwell time in hours
Number of Needle Sticks [up to 48 hours]
Prior to gaining successful access
Number of Insertion Attempts [up to 48 hours]
For ultrasound guided access
Emergency Department (ED) Length of Stay [up to 48 hours]
in hours
Hospital Length of Stay [up to 48 hours]
in hours
Patient Satisfaction [immediately post intervention/baseline and at 48 hours past baseline]
this is a single question measuring satisfaction with the intervention overall on a Likert Scale 1-10,
Number of Insertion Related Complications [up to 48 hours]
Includes failed attempts, arterial punctures, infiltrations, hematoma formations
Number of Dwell Related Complications [up to 48 hours]
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
Time to Access [up to 24 hours]
minutes from procedure start to procedure completion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT05607238

Other Study ID Numbers:

IRB00089914

First Posted:

Nov 7, 2022

Last Update Posted:

Jan 6, 2023

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wake Forest University Health Sciences

IV access

ultrasound guided IV

emergency care

Study Results

No Results Posted as of Jan 6, 2023