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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AccuCath 2.25" BC Intravascular Catheter | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuCath 2.25" BC Intravascular Catheter | Device | Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| First Attempt Success Rate | At initial IV insertion attempt, generally from 3-15 minutes | |
| Number of Catheter Attempts Required to Complete Successful PIV Placement | At IV insertion attempt, generally from 3-15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Catheter Placement | Time will be measured from initial vessel insertion through successful cannulation | At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes |
| Complications |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts Prior to AccuCath 2.25" Use | Count of catheter attempts during initial insertion before patient identified as difficult IV access | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Raio, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore - Long Island Jewish Health System | Manhasset | New York | 11030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AccuCath 2.25" BC Intravascular Catheter | Use of AccuCath 2.25" Blood Control (BC) peripheral intravenous (PIV) 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. AccuCath 2.25" BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AccuCath 2.25" BC Intravascular Catheter | 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. AccuCath 2.25" BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | First Attempt Success Rate | Posted | Count of Participants | Participants | At initial IV insertion attempt, generally from 3-15 minutes |
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Treatment emergent anticipated and unanticipated serious and non-serious adverse events were recorded from catheter insertion until catheter removal. Catheter dwell time usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days).
The number and proportion of subjects in the Safety Patient Set reporting any given adverse event were tabulated according to the worst severity reported during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AccuCath 2.25" BC Intravascular Catheter | 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. AccuCath 2.25" BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infiltration | Product Issues | CTCAE (4.0) | Non-systematic Assessment | Infiltration results when the IV catheter is dislodged and fluid infuses into the tissue. It is characterized by edema, pallor, decreased skin temperature around the site, and pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Gilbert, BSN, RN | Bard Access Systems, Inc. | 407-489-0935 | Gina.Gilbert@crbard.com |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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
| During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days |
| Dwell Time | IV dwell time in hours until IV is no longer needed or complicates. | 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) |
| Completion of Therapy | Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal. | During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days |
| 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. | At end of IV insertion, first 3-15 minutes of procedure |
| 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. | at IV removal, which can be up to a maximum of 29 days |
| Year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Primary | Number of Catheter Attempts Required to Complete Successful PIV Placement | Posted | Median | Full Range | Number of Catheters | At IV insertion attempt, generally from 3-15 minutes |
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| Secondary | Time to Catheter Placement | Time will be measured from initial vessel insertion through successful cannulation | Posted | Median | Full Range | minutes | At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes |
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| Secondary | 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 | The total number of complications resulting from all 120 IV placement procedures is reported. | Posted | Number | Complications | During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days | IV procedures | IV procedures |
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| Secondary | Dwell Time | IV dwell time in hours until IV is no longer needed or complicates. | Admitted patients | Posted | Median | Full Range | hours | 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) |
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| Secondary | Completion of Therapy | Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal. | Posted | Count of Participants | Participants | During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days |
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| Secondary | 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. | Posted | Median | Full Range | units on a scale | At end of IV insertion, first 3-15 minutes of procedure |
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| Secondary | 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. | Posted | Median | Full Range | units on a scale | at IV removal, which can be up to a maximum of 29 days |
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| Other Pre-specified | Number of Attempts Prior to AccuCath 2.25" Use | Count of catheter attempts during initial insertion before patient identified as difficult IV access | Posted | Median | Full Range | number of attempts | 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 |
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| 0 |
| 120 |
| 6 |
| 120 |
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