Blood Sampling Functionality of Extended Dwell Catheters

Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection

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.

Study Overview

• Status: Completed
• Conditions: Vascular Access Complication; IV Catheter-Related Infection or Complication; Peripheral Venous Access
• Intervention / Treatment: Device: Extended dwell catheters

Detailed Description

Many patients will require ongoing blood draws for laboratory testing while in the hospital and hospitals generally avoid using peripheral IVs for laboratory testing as it is associated with an increase in complications such as irritation and infiltration (where the IV medication or fluid will leak out of the vein and into the surrounding tissue). Therefore, patients are often required to have multiple needlesticks throughout their hospital stay which can lead to patient dissatisfaction and anxiety.

Extended dwell catheters (EDC) offer an alternative to peripheral 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. While there is not a lot of evidence about how well these catheters will allow blood to be drawn, an EDC can be used to obtain blood for routine blood draws and potentially eliminate the need for additional needle sticks.

Eligible patients in this study will be randomized to two groups based on placement site: experimental group (forearm) or the 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. 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. The research team will capture images on the ultrasound machine that is used for initial assessment of sites per routine care. If the vein is appropriate for cannulation based on these assessments, the Advance Practice Provider (APP) will insert the catheter. If the APP on the Vascular Access Team (VAT) has no adequate target visualized in the randomly selected site, the inserter may evaluate another site that is more suitable for cannulation. Functionality will be confirmed by ability to aspirate by drawing back into a syringe and then the catheter flushed with 5cc of normal saline without resistance. The site of insertion will be recorded and pertinent information will be collected similar to other catheter placements. Securement of the placed IV will be standardized between groups. Daily assessment of functionality (patency of the catheter) will be performed by the research team for the life of the catheter while hospitalized (up to 30 days).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital - Royal Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inpatient Inclusion Criteria:

1. Consult to VAT for vascular access device placement
2. Patient requires peripheral access
3. Adults >18 years of age

ED Patient Inclusion Criteria

1. Age > 18 years old
2. Difficult vascular access defined as: patient has no visible veins (>2mm) or palpable veins
3. Anticipated hospital admission

All patients meeting inclusion criteria will be pre-scanned prior to formal enrollment to identify diameter of target veins and calculate a catheter to vein ratio at the potential insertion site. Patients must meet this criteria in both upper arm and forearm locations prior to enrollment and randomization.

Exclusion Criteria:

Patients will be excluded if:

1. Multiple lumens required
2. Functional vascular access device exists proximal to the targeted area of insertion. This does not include superficial non-ultrasound guided peripheral IVs.
3. Upper extremity cannot be accessed due to a coexisting medical condition
4. Cognitively impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; 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.
Active Comparator: Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis	The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation.	During hospitalization, up to 30 days
Catheter Dwell Time/Survival	Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of hours until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization.	During hospitalization, up to 30 days

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Amit Bahl, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: vascular access; IV survival; intravenous access
• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections
• Other Study ID Numbers: 2020-053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No