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NCT01382524 · ClinicalTrials.gov registry record
Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems
A clinical trial, sponsored by Solventum US.
- Completed
- Registry status
- 682
- Enrollment target
NCT01382524 is a clinical trial that has completed, run by Solventum US. The registered enrollment target is 682 participants.
The verdict
NCT01382524 has completed, sponsored by Solventum US.
- COMPLETED
- Registry status
- 682 participants
- Enrollment target
Study Summary
Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the U.S. in 2009. These short (\< 3 inches) peripherally inserted IV catheters are vital for providing patients with needed: 1) fluid, electrolyte, nutrient and blood product replacement, 2) medicines and 3) diagnostic solutions (dyes). However, these IV catheters have inherent risks or potential complications which may result from poor catheter securement or stabilization. When a PIV catheter is not properly secured, motion and micro-motion within the vessel cause injury to the vein. This damage to the vein is a primary cause of phlebitis, a distressing complication of PIV therapy. Additional complications of inadequate stabilization of the PIV catheter are infiltration, leaking at the insertion site, pain, infection and dislodgement. According to Royer (2003), the most common reason for PIV catheter failure is infiltration and dislodgement. Infiltration is more dependent on keeping the extremity still, where phlebitis is dependent on injuries due to the chemical nature of the drugs and fluids infused or by the physical trauma to the endothelium from IV pushes. The results of these complications are costly and can be serious if another vein cannot be immediately accessed or if the infiltrated infusate causes tissue necrosis. An unscheduled restart of another PIV catheter causes a delay in patient treatment, patient discomfort, patient dissatisfaction, safety concerns, nursing interruptions and additional costs. Actual costs associated with PIV catheter restarts include materials and nursing resources; yet intangibles such as, treatment for patient complications and patient dissatisfaction may be far more costly. One way to reduce the incidence of PIV catheter-associated complications is to use technologies that help reduce catheter movement thereby improving catheter stabilization. In addition to stabilization platforms added to the peripheral IV catheter design, catheter stab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01382524
The ClinicalTrials.gov registry entry for NCT01382524 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 682 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Solventum US, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01382524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01382524 about?
NCT01382524 is a clinical study titled "Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems". Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the U.S. in 2009. These short (\< 3 inches) peripherally inserted IV catheters are vital for providing patients with needed: 1) fluid, electrolyte, nutrient and blood product replacement, 2) medicines and 3) diagn...
What is the current status of trial NCT01382524?
This trial is currently completed. The enrollment target is 682 participants. The study started on 2011-06. Estimated completion is 2012-09.
Who is sponsoring clinical trial NCT01382524?
This trial is sponsored by Solventum US, which has 41 total clinical trials registered on ClinicalTrials.gov.
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