Blood Sampling Functionality of Extended Dwell Catheters

NCT04409418 | Completed Results FDA Device

• 1 other identifier: 2020-053
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral Intravenous (IVs) especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.

Conditions

IV Catheter-Related Infection or Complication; Vascular Access Complication; Peripheral Venous Access

Keywords

intravenous access; vascular access; IV survival

Outcome Measures

Primary Outcomes (1)

• Blood Sampling Functionality

  Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization.

  During hospitalization, up to 30 days

Secondary Outcomes (2)

• Catheter Dwell Time/Survival

  During hospitalization, up to 30 days

• Thrombosis

  During hospitalization, up to 30 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa.

Device: Extended dwell catheters

Control Group

ACTIVE COMPARATOR

Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa.

Device: Extended dwell catheters

Interventions

Extended dwell catheters DEVICE

EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consult to VAT for vascular access device placement
• Patient requires peripheral access
• Adults \>18 years of age
• Age \> 18 years old
• Difficult vascular access defined as: patient has no visible veins (\>2mm) or palpable veins
• Anticipated hospital admission

You may not qualify if:

• Patients will be excluded if:
• Multiple lumens required
• Functional vascular access device exists proximal to the targeted area of insertion. This does not include superficial non-ultrasound guided peripheral IVs.
• Upper extremity cannot be accessed due to a coexisting medical condition
• Cognitively impaired

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Results Point of Contact

• Title: Dr. Amit Bahl
• Organization: William Beaumont Hospitals

amit.bahl@corewellhealth.org

248 898-9111

Study Officials

• Amit Bahl, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Emergency Medicine Ultrasound

Model Details: Prospective, single-site, randomized

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: June 23, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)