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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05607238
Other study ID # IRB00089914
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2023
Est. completion date September 2023

Study information

Verified date October 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound Guided Vascular Access - Midline catheter
Ultrasound guided vascular access with a midline IV catheter
Ultrasound Guided Vascular Access - peripheral IV
Ultrasound guided vascular access with a peripheral IV catheter

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of needle punctures in a 24 hour period (patient reported) up to 48 hours
Secondary Duration of Successful Access IV/Cath dwell time in hours up to 48 hours
Secondary Number of Needle Sticks Prior to gaining successful access up to 48 hours
Secondary Number of Insertion Attempts For ultrasound guided access up to 48 hours
Secondary Emergency Department (ED) Length of Stay in hours up to 48 hours
Secondary Hospital Length of Stay in hours up to 48 hours
Secondary 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
Secondary Number of Insertion Related Complications Includes failed attempts, arterial punctures, infiltrations, hematoma formations up to 48 hours
Secondary 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
Secondary Time to Access minutes from procedure start to procedure completion up to 24 hours
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