Catheter ComplicationsPIV SecuralNCT01382524
Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems
An observational study of Catheter Complications, run by Solventum US LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Complications
- How many people
- 682 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population for this study will be male and female patients who are at least 18 years of age or an emancipated minor, require a peripheral IV catheter for an anticipated three days (72 hours) or longer
Who may be able to join
- At least 18 years of age, unless an emancipated minor
- A patient who is admitted or going to be admitted to the hospital
- Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer.
- Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the securement protocol.
Who cannot join
- Is a current participant or a past participant in this study
- If the study PIV catheter will cross a joint or the catheter hub will hang off the fingers
- If the study PIV catheter site will be placed below an old infusion site
- If the study PIV site needs to be immobilized with a splint or other devices
- Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes or liquid skin protectants
- Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol
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- Has or has had a previous IV catheter related phlebitis or infiltration during this hospitalization.
- Will have a vesicant administered through the study catheter, e.g. Dilantin
- Will require a power injection for a radiologic procedure during participation in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina
About this study
Official title: Peripheral I.V. 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) 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.
Read more
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 stabilization devices and modified transparent film dressings also help to reduce catheter movement and could possibly eliminate the need for routine catheter site changes.
Therefore, the purpose of this study is to: 1) compare the number of PIV securement-related complications and PIV catheter restarts of one stabilization system to another stabilization system and 2) to determine which system provides a cost savings.
Read the detailed description
See brief summary
- Conditions
- Catheter Complications
- Keywords
- PIV therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization system A | A commercialized stabilization dressing using a winged PIV catheter. | |
| Stabilization System B | A commercialized stabilization device using a non-winged PIV catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIV Catheter complication rates
The primary endpoint for the study is the difference between the number and type of PIV-related complications (phlebitis, infiltration, dislodgement, leakage, local site infection and catheter line associated infection) between the two stabilization groups.
Measured: Anticipated to be up to 4 days per participant
Secondary outcomes (1)
Cost effectiveness
The secondary endpoints are overall and specific complication rates, incidence of unscheduled restarts, incremental cost effective ratio for one stabilization system to another stabilization system.
Measured: Anticipated to be up to 4 days per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Randall Coombs, MD, Principal investigator, University of North Carolina, Chapel HillCedric Lefebvre, MD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382524
- Sponsor's protocol ID
- 05-011427
- Acronym
- PIV Secural
- Status last verified
- Sep 2024
- First submitted
- 24 Jun 2011
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral I.V. Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems
- ClinicalTrials.gov ID
- NCT01382524
- Acronym / sponsor ID
- PIV Secural / 05-011427
- Conditions
- Catheter Complications
- Keywords
- PIV therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 stabilization devices and modified transparent film dressings also help to reduce catheter movement and could possibly eliminate the need for routine catheter site changes.
Therefore, the purpose of this study is to: 1) compare the number of PIV securement-related complications and PIV catheter restarts of one stabilization system to another stabilization system and 2) to determine which system provides a cost savings.
Detailed description
See brief summary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization system A | – | –A commercialized stabilization dressing using a winged PIV catheter. |
| Stabilization System B | – | –A commercialized stabilization device using a non-winged PIV catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this study will be male and female patients who are at least 18 years of age or an emancipated minor, require a peripheral IV catheter for an anticipated three days (72 hours) or longer
Key inclusion criteria (5 listed)
- At least 18 years of age, unless an emancipated minor
- A patient who is admitted or going to be admitted to the hospital
- Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer.
- Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the securement protocol.
Key exclusion criteria (9 listed)
- Is a current participant or a past participant in this study
- If the study PIV catheter will cross a joint or the catheter hub will hang off the fingers
- If the study PIV catheter site will be placed below an old infusion site
- If the study PIV site needs to be immobilized with a splint or other devices
- Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes or liquid skin protectants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PIV Catheter complication rates
Time frame: Anticipated to be up to 4 days per participant
The primary endpoint for the study is the difference between the number and type of PIV-related complications (phlebitis, infiltration, dislodgement, leakage, local site infection and catheter line associated infection) between the two stabilization groups.
1 secondary outcome
Cost effectiveness
Time frame: Anticipated to be up to 4 days per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Coombs, MD principal investigator
University of North Carolina, Chapel Hill
Cedric Lefebvre, MD principal investigator
Wake Forest University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Complications, run by Solventum US LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIV Catheter complication rates (time frame: Anticipated to be up to 4 days per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.