Clinical trial NCT04409418: Blood Sampling Functionality of Extended Dwell Catheters
Official title: Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IV Catheter-Related Infection or Complication
Vascular Access Complication
Peripheral Venous Access
Keywords: intravenous access
vascular access
IV survival
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-site, randomized
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Blood Sampling Functionality
timeFrame: During hospitalization, up to 30 days
Secondary outcomes:
measure: Catheter Dwell Time/Survival
timeFrame: During hospitalization, up to 30 days
measure: Thrombosis
timeFrame: During hospitalization, up to 30 days
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Amit Bahl, MD
role: PRINCIPAL_INVESTIGATOR
References: