Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement (NCT04262947) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement
Stopped: COVID epidemic
United States38 participantsStarted 2020-01-22
Plain-language summary
The objective of this project is to define the effectiveness and therefore the role of NIR vein finders in adult patients with difficult peripheral venous access. The specific objective of the proposed randomized controlled trial is to test the clinical success rate of placing peripheral venous catheters in 'difficult' access patients using traditional peripheral venous catheter placement compared to two established methods utilizing NIR vein imaging. The investigators hypothesize that the capability to successfully place lasting peripheral venous catheters is increased with the adjunct of the imaging technology, reducing the number of failed needle sticks, reducing the number of peripheral venous catheters placed throughout a patient's hospital stay, and reducing the need for more invasive catheters such as PICC lines.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* non-pediatric in-hospital patients (≥15 years of age, inpatient and outpatient setting)
* willing to provide research authorization
* scheduled and consented to undergo peripheral venous cannulation of one of the upper extremities to be performed by one of the members of the Vascular Access Team
* determined to be a difficult peripheral venous access defined by one of the following criteria in alignment to the A-DIVA scale to be assessed by one of the members of the Vascular Access Team \[8\]:
* failed inspection for more than one visible or palpable suitable vein through conventional methods
* failed at least one attempt of peripheral venous cannulation through any methods
* history of difficult peripheral venous access
* greatest diameter of target vein less than 3mm determined by conventional methods
Exclusion Criteria:
* clinical contraindication for placement of peripheral venous catheter, including:
* severe bilateral upper extremity edema
* severe bilateral upper extremity skin burn
* severe bilateral upper extremity cellulitis
* history of bilateral axillary lymphadenectomy
* known severe cardiovascular or pulmonary compromise demanding minimization of procedure time, such as:
* severe shock with severe cardiovascular instability
* active CPR
* major uncontrolled hemorrhage
* any condition for which the primary healthcare provider is requesting emergent venous access
* scheduled PICC or midline catheter placement
* non-English-speaking patient…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Successful Initial IV Placement