Patient Perspective Midline Catheter in the Emergency Department

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

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

Conditions
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Patient Satisfaction, Patient Preference

Intervention / Treatment
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* Procedure: Ultrasound Guided Vascular Access - Midline catheter
* Procedure: Ultrasound Guided Vascular Access - peripheral IV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV access, ultrasound guided IV, emergency care