Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05869877
Other study ID # HHC-2022-0276
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 25, 2024
Est. completion date May 1, 2024

Study information

Verified date February 2024
Source Hartford Hospital
Contact Lee J Steere, ADN
Phone 860-614-8254
Email Lee.Steere@hhchealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 106
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Bundled
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hartford Hospital Vygon GmbH & Co. KG

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
Secondary Dwell Time To compare dwell times between the 2 groups. Dwell time is defined as the time from line insertion to line removal. 1 year
Secondary Cost Impact To compare cost with additional PIVC's inserted if PIVC failed to make it until the end of therapy 1 year
Secondary Outcome Analysis To compare IV related complications between the 2 groups (infiltrations, occlusions, phlebitis) 1 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04054128 - Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients Phase 4
Recruiting NCT05729321 - Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Recruiting NCT05334225 - Assessing the Knowledge and Self-confidence of Healthcare Workers to Perform Transurethral Catheterization: A Multicenter Survey
Completed NCT06106659 - Comparison of Clinical Outcomes of Mini Midline Catheters With Different Placement Sites: a Randomized Controlled Trial N/A
Completed NCT03655106 - Ultrasound Guided Catheter Length Survivability N/A
Not yet recruiting NCT06014099 - Research on the Application of Blood Collection Through Midline Catheters of Different Lengths N/A
Completed NCT03693755 - Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane N/A
Not yet recruiting NCT06019897 - Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection
Not yet recruiting NCT06149533 - Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients Phase 3
Completed NCT01465594 - Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy N/A
Recruiting NCT06001827 - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study N/A
Completed NCT04569474 - Peripheral IV Dressing and Phlebitis in Patients From Amazon N/A
Completed NCT05814887 - Reduction of Mechanical IV Complication Using a New Medical Device N/A
Recruiting NCT05741866 - Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) N/A
Completed NCT06312215 - Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services N/A
Recruiting NCT04359056 - Clinical Pharmacy for Patients With a PICC Line N/A
Recruiting NCT04548713 - CLiCK in the Critical Care Unit N/A
Completed NCT04285775 - A Novel Device for Surveillance of Vascular Access Sites for Bleeding
Completed NCT05446987 - Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications N/A
Not yet recruiting NCT05354921 - Indwelling vs Intermittent Catheterization Pilot Study N/A