Catheter ComplicationsNCT05869877
The PIV5Rights Safety and Quality Bundle
A study testing Bundled in people with Catheter Complications, run by Hartford Hospital.
Trial summary
Purpose of this study is to see if a Peripheral Intravenous Catheter PIVC will last longer if inserted by a Registered Nurse (RN) who specializes in inserting PIVCs. Main question it aims to answer: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Complications
- What is being tested?
- Bundled
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2024to 1 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older with not upper limit
- requires an IV for fluid and or medication administration
- able to read and write English and willing to complete written, informed consent
Who cannot join
- Unable to speak and read English
- Vulnerable populations such as minors (under age of 18)
- Incompetent or mentally challenged
- Prisoners
- Pregnant women or the unborn
- presented in the hospital prior to study start date
Trial locations and contacts
No sites are listed yet.
About this study
Purpose of this study is to see if a Peripheral Intravenous Catheter PIVC will last longer if inserted by a Registered Nurse (RN) who specializes in inserting PIVCs. Main question it aims to answer:
- We believe that the use of the ultrasound, an RN who specializes in PIVC placement with the use of ultrasound and the use of best of class medical technology, may improve first stick success with PIVC insertion and the length of time the PIVC stays in place without showing any related complications
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent, patients will be randomized using Research Randomizer. At that time, the IV Therapist will insert a PIVC using standard of care medical equipment (control) or use ultrasound guidance, if needed, to insert a PIVC using the bundle with the best of class medical devices. Daily, a research RN will round, assess the site and take a picture. When therapy is complete or the PIVC malfunctions, the research RN will document the reason why the PIVC failed and that patient will no longer remain in the study.
- Conditions
- Catheter Complications
- Being tested
- Bundled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BundledDevice
An peripheral intravenous catheter will be inserted by an RN specially trained in PIVC placement, with or without ultrasound. Using best of class medical products, will evaluate dwell time and complications of the PIVC inserted using a bundled approach versus one inserted with the bundle
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Proficient RN who works in IV Therapy Department - PIVC inserted without using ultrasound; non-bordered transparent dressing; 1-1.25 inch catheter; microbore extension set with neutral needleless connector; transpore tape. Standard of care |
| Bundled | Experimental | Proficient RN who works in IV Therapy Department - 6 cm catheter inserted with or without ultrasound; chlorhexidine embedded transparent bordered dressing; transpore tape; microbore extension set with antireflux needleless connector Receives: Device: Bundled |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 PIVC Per Patient Stay
To compare the proportion of patients for whom the initial catheter insertion is sufficient for their duration of care across the two groups
Measured: 1 year
Secondary outcomes (3)
Dwell Time
To compare dwell times between the 2 groups. Dwell time is defined as the time from line insertion to line removal.
Measured: 1 year
Cost Impact
To compare cost with additional PIVC's inserted if PIVC failed to make it until the end of therapy
Measured: 1 year
Outcome Analysis
To compare IV related complications between the 2 groups (infiltrations, occlusions, phlebitis)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start25 Mar 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized controlled trial evaluating a peripheral intravenous catheter (PIVC) inserting using a bundled approach. Will evaluate the for extended dwell time and less complications compared to a PIVC using a non-bundled approach
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Responsible party
- Principal investigator, Lee Steere, Hartford Hospital
- Investigators
- Lee J Steere, ADN, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869877
- Sponsor's protocol ID
- HHC-2022-0276
- Status last verified
- Feb 2024
- First submitted
- 9 May 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PIV5Rights Safety and Quality Bundle
- ClinicalTrials.gov ID
- NCT05869877
- Acronym / sponsor ID
- HHC-2022-0276
- Conditions
- Catheter Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- 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.
Purpose of this study is to see if a Peripheral Intravenous Catheter PIVC will last longer if inserted by a Registered Nurse (RN) who specializes in inserting PIVCs. Main question it aims to answer:
- We believe that the use of the ultrasound, an RN who specializes in PIVC placement with the use of ultrasound and the use of best of class medical technology, may improve first stick success with PIVC insertion and the length of time the PIVC stays in place without showing any related complications
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent, patients will be randomized using Research Randomizer. At that time, the IV Therapist will insert a PIVC using standard of care medical equipment (control) or use ultrasound guidance, if needed, to insert a PIVC using the bundle with the best of class medical devices. Daily, a research RN will round, assess the site and take a picture. When therapy is complete or the PIVC malfunctions, the research RN will document the reason why the PIVC failed and that patient will no longer remain in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial evaluating a peripheral intravenous catheter (PIVC) inserting using a bundled approach. Will evaluate the for extended dwell time and less complications compared to a PIVC using a non-bundled approach
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Proficient RN who works in IV Therapy Department - PIVC inserted without using ultrasound; non-bordered transparent dressing; 1-1.25 inch catheter; microbore extension set with neutral needleless connector; transpore tape. Standard of care |
| Bundled | Experimental | Device: BundledProficient RN who works in IV Therapy Department - 6 cm catheter inserted with or without ultrasound; chlorhexidine embedded transparent bordered dressing; transpore tape; microbore extension set with antireflux needleless connector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older with not upper limit
- requires an IV for fluid and or medication administration
- able to read and write English and willing to complete written, informed consent
Key exclusion criteria (6 listed)
- Unable to speak and read English
- Vulnerable populations such as minors (under age of 18)
- Incompetent or mentally challenged
- Prisoners
- Pregnant women or the unborn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BundledAn peripheral intravenous catheter will be inserted by an RN specially trained in PIVC placement, with or without ultrasound. Using best of class medical products, will evaluate dwell time and complications of the PIVC inserted using a bundled approach versus one inserted with the bundle | Device | Bundled |
Primary outcome
1 PIVC Per Patient Stay
Time frame: 1 year
To compare the proportion of patients for whom the initial catheter insertion is sufficient for their duration of care across the two groups
3 secondary outcomes
Dwell Time
Time frame: 1 year
Cost Impact
Time frame: 1 year
Outcome Analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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.
Lee J Steere, ADN principal investigator
Hartford Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bundled in people with Catheter Complications, run by Hartford Hospital.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee J Steere, ADN (860-614-8254, Lee.Steere@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 PIVC Per Patient Stay (time frame: 1 year). 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 28 Feb 2024.