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Funding Stopped
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The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIVS vascular access | Experimental | RIVS vascular access |
|
| Conventional vascular access | Active Comparator | Conventional vascular access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIVS vascular access | Device | Access to peripheral vasculature |
| |
| Measure | Description | Time Frame |
|---|---|---|
| IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt | A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement. | An access attempt usually ranges from 0 to 45 minutes in duration. |
| Summary of Major Complications | Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others. | Post-PIV placement until catheter removal (usually within 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time Required to Obtain Access | A secured flushed IV will be indicative of a successful PIV placement. | An access attempt usually ranges from 0 to 45 minutes in duration. |
| Second Stick Success Rate |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S Stuart, MD | Washington Outpatient Surgery Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Outpatient Surgery Center | Fremont | California | 94538 | United States | ||
| St. Vincent's Medical Center |
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Prior to assignment to groups, two subjects withdrew from the study. Also prior to group assignment, one subject did not have a consent form and was excluded from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | RIVS Vascular Access | RIVS vascular access RIVS vascular access: Access to peripheral vasculature |
| FG001 | Conventional Vascular Access | Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RIVS Vascular Access | RIVS vascular access RIVS vascular access: Access to peripheral vasculature |
| BG001 | Conventional Vascular Access | Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt | A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement. | Posted | Number | participants | An access attempt usually ranges from 0 to 45 minutes in duration. |
|
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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 | RIVS Vascular Access | RIVS vascular access RIVS vascular access: Access to peripheral vasculature |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Vasular Complication | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Gilbert | Bard Access Systems, Inc. | 407-489-0835 | Gina.Gilbert@crbard.com |
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| Conventional vascular access |
| Device |
Vascular access using conventional venous access device |
|
A secured flushed IV will be indicative of a successful PIV placement.
| An access attempt usually ranges from 0 to 45 minutes in duration. |
| Summary of Minor Complications | Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient. | Post-PIV placement until catheter removal (usually within 4 days) |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Sex data were missing for two (2) subjects. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
|
| Primary | Summary of Major Complications | Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others. | Posted | Number | participants | Post-PIV placement until catheter removal (usually within 4 days) |
|
|
|
| Secondary | Time Required to Obtain Access | A secured flushed IV will be indicative of a successful PIV placement. | Posted | Mean | Standard Deviation | minutes | An access attempt usually ranges from 0 to 45 minutes in duration. |
|
|
|
| Secondary | Second Stick Success Rate | A secured flushed IV will be indicative of a successful PIV placement. | Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow Module because not all participants required a second attempt at catheter placement. | Posted | Number | participants | An access attempt usually ranges from 0 to 45 minutes in duration. |
|
|
|
|
| Secondary | Summary of Minor Complications | Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient. | Posted | Number | participants | Post-PIV placement until catheter removal (usually within 4 days) |
|
|
|
| 0 |
| 84 |
| 1 |
| 84 |
| EG001 | Conventional Vascular Access | Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device | 0 | 88 | 0 | 88 |
The Principal Investigators may publish or present the study results with prior consent of the Sponsor, but will not disclose confidential information. Prior to submission by a Principal Investigator for publication or presentation, the Sponsor will be provided with the opportunity to review the submission for confidential information and accuracy.