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The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.
Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AccuCath Intravenous Catheter System | Experimental | AccuCath Intravenous Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuCath Intravenous Catheter System | Device | AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt | The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access. | Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complications of Peripheral IV Therapy | Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days). | Study exit/at catheter removal expected to be up to 7 days post placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman R Anderson, RN | Evangelical Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelical Community Hospital | Lewisburg | Pennsylvania | 17837 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27379678 | Result | Anderson NR. Influencing Patient Satisfaction Scores: Prospective One-Arm Study of a Novel Intravenous Catheter System With Retractable Coiled-Tip Guidewire Compared With Published Literature for Conventional Peripheral Intravenous Catheters. J Infus Nurs. 2016 Jul-Aug;39(4):201-9. doi: 10.1097/NAN.0000000000000173. |
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Patients were enrolled from April 2013 through June 2014. Patients were admitted to the inpatient units at Evangelical Community Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | AccuCath Intravenous Catheter Device | AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Inpatients requiring IV therapy during hospital admission of > 24 hours.
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| ID | Title | Description |
|---|---|---|
| BG000 | AccuCath Intravenous Catheter Device | AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt | The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access. | Inpatients requiring IV therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure |
|
During enrollment from April 2013 through June 2014.
IV complications are anticipated events during conventional IV therapy and occur about 47% of the time.
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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 Intravenous Catheter Device | AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular Complication | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Norman R. Anderson | Evangelical Community Hospital | 570-222-2000 | nanderson@evanhospital.com |
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| Completion of IV Therapy | Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days). | Study exit/at catheter removal expected to be up to 7 days post placement |
| Catheter Dwell Time | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days. | Study exit/at catheter removal expected to be up to 7 days post placement |
| Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion | Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5. | Baseline at catheter insertion in the first 3-15 minutes after procedure |
| Number of Participants Experiencing Adverse Events | Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy. | baseline, and up to catheter removal expected to be no more than 7 days post placement |
| Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal | Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5. | At catheter removal, which is expected to be up to 7 days post placement |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Patients With Complications of Peripheral IV Therapy | Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days). | Inpatient units requiring IV therapy. | Posted | Number | 95% Confidence Interval | percentage of patients | Study exit/at catheter removal expected to be up to 7 days post placement |
|
|
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| Secondary | Completion of IV Therapy | Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days). | Inpatients requiring IV therapy. | Posted | Count of Participants | Participants | Study exit/at catheter removal expected to be up to 7 days post placement |
|
|
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| Secondary | Catheter Dwell Time | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days. | Posted | Mean | 95% Confidence Interval | hours | Study exit/at catheter removal expected to be up to 7 days post placement |
|
|
|
| Secondary | Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion | Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5. | Inpatients requiring IV therapy | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline at catheter insertion in the first 3-15 minutes after procedure |
|
|
|
| Secondary | Number of Participants Experiencing Adverse Events | Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy. | Inpatients requiring IV therapy. | Posted | Number | participants | baseline, and up to catheter removal expected to be no more than 7 days post placement |
|
|
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| Secondary | Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal | Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5. | Inpatients requiring IV therapy | Posted | Number | 95% Confidence Interval | percentage of participants | At catheter removal, which is expected to be up to 7 days post placement |
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| 0 |
| 95 |
| 17 |
| 95 |
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| Title | Measurements |
|---|
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| Leaking |
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| Dislodgement |
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