Patient Satisfaction Clinical Trial
Official title:
Patient Perspective of Midline Catheters Versus Ultrasound Guided Peripheral IVs for Difficult IV Access in the ED
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Status | Withdrawn |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 |
Verified date | October 2022 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
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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