Back to resultsProspective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
Primary Purpose
Vascular Access Complication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AccuCath 2.25" BC Intravascular Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Access Complication focused on measuring Difficult IV access, AccuCath, IV outcomes, patient satisfaction
Eligibility Criteria
Inclusion Criteria:
- Male or female, age > 18 years old;
- Capable and willing to give informed consent;
- English speaking;
- Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
- Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
- Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.
Exclusion Criteria:
- Male or female, < 18 years old;
- Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- Previous venous grafts or surgery at the target vessel access site;
- Subjects with lymphedema or status-post mastectomy on affected side;
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
Sites / Locations
- North Shore - Long Island Jewish Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AccuCath 2.25" BC Intravascular Catheter
Arm Description
Use of AccuCath 2.25" BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
Outcomes
Primary Outcome Measures
First Attempt Success Rate
Number of Catheter Attempts Required to Complete Successful PIV Placement
Secondary Outcome Measures
Time to Catheter Placement
Time will be measured from initial vessel insertion through successful cannulation
Complications
Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site
Dwell Time
IV dwell time in hours until IV is no longer needed or complicates.
Completion of Therapy
Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.
Patient Satisfaction
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Patient Satisfaction
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02449798
Brief Title
Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
Official Title
A Prospective Feasibility Trial of AccuCath 2.25" BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department.
Detailed Description
A one arm, prospective feasibility study using the AccuCath 2.25" BC Intravascular Catheter System placed in the upper arm with ultrasound guidance, and the lower arm with and without ultrasound guidance based on clinical assessment. Subjects will be subjected to a maximum of 4 attempts. If unsuccessful by the 4th attempt, alternatives will be considered as per current standard of care.
Currently multiple IV attempts are made in difficult IV access patients without success. Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication. The study will evaluate the feasibility of AccuCath 2.25" BC as a low risk, lower cost alternative for this patient population in lieu of using a midline, peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication
Keywords
Difficult IV access, AccuCath, IV outcomes, patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AccuCath 2.25" BC Intravascular Catheter
Arm Type
Experimental
Arm Description
Use of AccuCath 2.25" BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
Intervention Type
Device
Intervention Name(s)
AccuCath 2.25" BC Intravascular Catheter
Other Intervention Name(s)
AccuCath, AccuCath peripheral IV, AccuCath IV device, AccuCath catheter system
Intervention Description
Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.
Primary Outcome Measure Information:
Title
First Attempt Success Rate
Time Frame
At initial IV insertion attempt, generally from 3-15 minutes
Title
Number of Catheter Attempts Required to Complete Successful PIV Placement
Time Frame
At IV insertion attempt, generally from 3-15 minutes
Secondary Outcome Measure Information:
Title
Time to Catheter Placement
Description
Time will be measured from initial vessel insertion through successful cannulation
Time Frame
At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes
Title
Complications
Description
Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site
Time Frame
During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Title
Dwell Time
Description
IV dwell time in hours until IV is no longer needed or complicates.
Time Frame
Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)
Title
Completion of Therapy
Description
Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.
Time Frame
During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Title
Patient Satisfaction
Description
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Time Frame
At end of IV insertion, first 3-15 minutes of procedure
Title
Patient Satisfaction
Description
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Time Frame
at IV removal, which can be up to a maximum of 29 days
Other Pre-specified Outcome Measures:
Title
Number of Attempts Prior to AccuCath 2.25" Use
Description
Count of catheter attempts during initial insertion before patient identified as difficult IV access
Time Frame
Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, age > 18 years old;
Capable and willing to give informed consent;
English speaking;
Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.
Exclusion Criteria:
Male or female, < 18 years old;
Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
Previous venous grafts or surgery at the target vessel access site;
Subjects with lymphedema or status-post mastectomy on affected side;
Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Raio, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore - Long Island Jewish Health System
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
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