Blood Sampling Functionality of Extended Dwell Catheters

Vascular Access Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409418
• Other study ID #: 2020-053
• Status: Completed
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 eliminiate 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• IV Catheter-Related Infection or Complication
• Peripheral Venous Access
• Vascular Access Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Beaumont Hospital - Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Sampling Functionality	Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of days until failure to aspirate blood identified during follow-up assessment during hospitalization.	During hospitalization, up to 30 days
Secondary	Catheter Dwell time/Survival	Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of days until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization. Duration of dwell and functional failure of the catheter will be employed to estimate catheter survival.	During hospitalization, up to 30 days
Secondary	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