search
Back to results

Blood Sampling Functionality of Extended Dwell Catheters

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extended dwell catheters
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IV Catheter-Related Infection or Complication focused on measuring intravenous access, vascular access, IV survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beaumont Hospital - Royal OakRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 27, 2020
Last Updated
October 28, 2022
Sponsor
William Beaumont Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT04409418
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IV Catheter-Related Infection or Complication, Vascular Access Complication, Peripheral Venous Access
Keywords
intravenous access, vascular access, IV survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-site, randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extended dwell catheters
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Sampling Functionality
Description
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.
Time Frame
During hospitalization, up to 30 days
Secondary Outcome Measure Information:
Title
Catheter Dwell time/Survival
Description
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.
Time Frame
During hospitalization, up to 30 days
Title
Thrombosis
Description
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.
Time Frame
During hospitalization, up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inpatient Inclusion Criteria: Consult to VAT for vascular access device placement Patient requires peripheral access Adults >18 years of age ED Patient Inclusion Criteria Age > 18 years old Difficult vascular access defined as: patient has no visible veins (>2mm) or palpable veins 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Scribner, RN
Phone
248-898-5590
Email
Lauren.Scribner@beaumont.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Bahl, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Blood Sampling Functionality of Extended Dwell Catheters

We'll reach out to this number within 24 hrs