Does a Novel Needle Over Catheter Device Improve First Pass Success and Decrease Complications

NCT ID: NCT06547294

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-09-30

Brief Summary

Emergency Department Patients who were to get intravenous (IV) access through routine medical care will receive it through trademarked catheter via convenience sample. Patient and clinician experience, including adverse events, will be recorded. A standardized data entry sheet will be collected at time of enrollment, and then daily thereafter while the subject has the IV. The data collected will remain anonymous.

Detailed Description

Identification of Subjects:

The emergency department is a designated participating unit providing subjects with medical care that are anticipated to be placed in the observation unit or admitted to an inpatient unit. Subjects who meet inclusion criteria will be consented to be included in the study.

Assignment of Subject Identification Number:

A unique identification number will be given to study subjects. Subject numbers will be assigned in sequential order. The subject number will consist of 6 characters. The first three characters will designate the manufacturer-specific protocol number (SVI). The last three characters will designate the subject by number in sequential order.

Informed Consent:

The nurse trained in placing this device will first consent the patient with written forms provided. All protocol nurses trained in this device will also have completed CITI training courses per our institutional guidelines.

Treatment Assignment:

Within this single arm study, subjects will be assigned to the study in a single treatment group. All patients in the convenience sample who would have received a standard stocked intravenous catheter will instead receive an Osprey catheter provided by the manufacturer. They will be compared against historical controls. Historical controls will be collected from a review of relevant literature, which has been determined to be stable across time and region.

Data Collection Method A Case Report Form (CRF) will be utilized to collect insertion related study data. The CRF will not include any patient identifying information such as name or medical identification number. The subject's demographic (age, race, and gender); baseline information (comorbidities); type of medications/fluids delivered will be documented from already captured Epic documentation.

A second Case Report Form (CRF) will be utilized to collect device performance study data. The CRF will not include any patient identifying information such as name or medical identification number. Device condition (ability to flush and obtain a blood return), Site condition (presence of redness, edema, drainage), patient response (level of pain) and dwell time will be extracted from Epic as this is the current standard practice to do so.

Active patients in the study will be maintained in a file on a secure drive that study personnel have to refer to to follow up active patients. Once active patients are no longer being followed daily, their name will be removed from that file. CRF forms will be filled out by hand and secured in a locked box. The data from both CRFs will be transcribed into a digital worksheet i.e. Microsoft Excel, which will be stored on a secured network drive maintained by the hospital.

Study Procedure Subjects will be admitted into the study according to the aforementioned criteria.

Hospital protocols will be followed for placement of the PIV. The site will be marked with date, time and initials of inserter. During and immediately after the IV placement procedure, the CRF will be initiated by staff associated with this study. If unsuccessful with first attempt at PIV placement, an attempt at another site with the same technique and device will be performed. This will be repeated according to facility policy and procedure until a successful PIV is in place or the physician decides to use an alternative therapy that no longer requires peripheral access. All catheters will be stabilized using the same form of stabilization device for uniformity in securement procedure throughout the duration of the study.

Daily assessments will occur per facility policy and procedure. An assessment will include; any level of pain and/or tenderness; presence of erythema; edema; induration; leakage of fluid or purulent drainage from the puncture site; catheter dysfunction (eg, resistance when flushing, absence of a blood return. Daily assessment will continue until the device is removed, completion of therapy or discharge. Once all the required data is collected, all de-identified data will be entered as a "data set" into the post procedure CRF for management/analysis. The final paper CRF will be placed in a study folder and maintained for record keeping and data analysis.

Conditions

Vascular Access Device Complications; Catheterization, Peripheral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osprey IV

Subjects enrolled will receive the study device as part of their routine medical care.

Group Type: EXPERIMENTAL

Osprey IV

Intervention Type: DEVICE

Utilization of novel needle over catheter commercial insertion device

Historical Controls

Intervention Type: OTHER

Outcome rates from catheter over needle devices (traditional manner of inserting peripheral IV)

Interventions

Osprey IV

Utilization of novel needle over catheter commercial insertion device

Intervention Type: DEVICE

Historical Controls

Outcome rates from catheter over needle devices (traditional manner of inserting peripheral IV)

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

1. Any gender, < 18 years old.

2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);

3. Previous venous grafts or surgery at the target vessel access site;

4. Currently involved in other investigational clinical trials (unless permission is granted by other study Pl)

5. Subjects who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Medical Center, Toms River, NJ

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerado Chiricolo, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Wood Johnson Barnabas Health

Locations

Robert Wood Johnson Barnabas Health Community Medical Center

Toms River, New Jersey, United States

Countries

United States

Related Links

https://www.skydancevascular.com/wp-content/uploads/2022/05/White-Paper-Advancing-Toward-the-Expansion-of-Catheter-Related-Blood-Stream-Infection-Reporting-to-Include-PIVs.pdf

Device White Paper

Other Identifiers

Pro2024001057

Identifier Type: -

Identifier Source: org_study_id