Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT06668766
Eligibility Criteria:
Inclusion Criteria:
* Adult (age 18 and older) patients presenting to the AMC ED with difficult IV access defined as any of the following:
* Two failed attempts at landmark based IV or US-guided peripheral vascular access by qualified ED staff
* Self-reported history of difficult IV access and one of the following:
* History of requiring 2 or more IV attempts on a previous visit (either self-reported or documented in the electronic medical record)
* Previous requirement for a rescue device after failed IV access attempt. These devices are as follows:
* US guided PIV
* Midline catheter
* Peripherally inserted central catheter
* Central venous catheter
* Intraosseous catheter
* History of or active comorbid disease state with known difficult IV access
* Prior or current implanted port device
* End stage renal disease with fistula
* Sickle cell disease
* History of or active intravenous drug use
Exclusion Criteria:
* Patients under the age of 18
* Known Prisoners
* Non-English-speaking patients
* Patients in whom the device cannot be stabilized due to tissue or treatments in bilateral extremities or available extremity (burns, complex humeral fractures, dialysis fistulas etc.)
* Patients lacking capacity to consent
* Patients unable to sign written consent
* Patients without identifiable target veins by ultrasonography
* Known pregnant patients
* Previously enrolled in this study
* Previously withdrawn from this study
* Presented when no study IV proceduralists are available
* Patients in whom obtaining informed consent and being enrolled in the study would put them at risk for obtaining time sensitive medical care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06668766
Study Brief:
Protocol Section:
NCT06668766