Vascular Access Complication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERIVS vascular access
Access to peripheral vasculature
DEVICEConventional vascular access
Vascular access using conventional venous access device
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years * Requires peripheral IV as determined by examining physician * Requires the IV when a study nurse or resident is available * Able to sign an informed consent
Exclusion criteria
* Active systemic or cutaneous infection or inflammation; * Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; * Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); * Currently involved in any other investigational clinical trials; * Previous vascular grafts or surgery at the target vessel access site; * Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; * Central line available * Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt | An access attempt usually ranges from 0 to 45 minutes in duration. | 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. |
| Summary of Major Complications | Post-PIV placement until catheter removal (usually within 4 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Required to Obtain Access | An access attempt usually ranges from 0 to 45 minutes in duration. | A secured flushed IV will be indicative of a successful PIV placement. |
| Second Stick Success Rate | An access attempt usually ranges from 0 to 45 minutes in duration. | A secured flushed IV will be indicative of a successful PIV placement. |
| Summary of Minor Complications | Post-PIV placement until catheter removal (usually within 4 days) | Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| RIVS Vascular Access RIVS vascular access
RIVS vascular access: Access to peripheral vasculature | 84 |
| Conventional Vascular Access Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device | 88 |
| Total | 172 |
Baseline characteristics
| Characteristic | RIVS Vascular Access | Conventional Vascular Access | Total |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 9.4 | 67.2 years STANDARD_DEVIATION 10.9 | 66.7 years STANDARD_DEVIATION 10.2 |
| Race/Ethnicity, Customized Asian | 14 participants | 16 participants | 30 participants |
| Race/Ethnicity, Customized Black | 10 participants | 10 participants | 20 participants |
| Race/Ethnicity, Customized Hispanic | 10 participants | 7 participants | 17 participants |
| Race/Ethnicity, Customized Other | 8 participants | 9 participants | 17 participants |
| Race/Ethnicity, Customized White | 42 participants | 44 participants | 86 participants |
| Sex: Female, Male Female | 36 Participants | 49 Participants | 85 Participants |
| Sex: Female, Male Male | 48 Participants | 37 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 84 | 0 / 88 |
| serious Total, serious adverse events | 0 / 84 | 0 / 88 |
Outcome results
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.
Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIVS Vascular Access | IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt | 60 participants |
| Conventional Vascular Access | IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt | 51 participants |
p-value: 0.05Fisher Exact
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.
Time frame: Post-PIV placement until catheter removal (usually within 4 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIVS Vascular Access | Summary of Major Complications | 0 participants |
| Conventional Vascular Access | Summary of Major Complications | 0 participants |
Secondary
Second Stick Success Rate
A secured flushed IV will be indicative of a successful PIV placement.
Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIVS Vascular Access | Second Stick Success Rate | 10 participants |
| Conventional Vascular Access | Second Stick Success Rate | 18 participants |
p-value: 0.8Fisher Exact
Secondary
Summary of Minor Complications
Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.
Time frame: Post-PIV placement until catheter removal (usually within 4 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIVS Vascular Access | Summary of Minor Complications | 1 participants |
| Conventional Vascular Access | Summary of Minor Complications | 0 participants |
Secondary
Time Required to Obtain Access
A secured flushed IV will be indicative of a successful PIV placement.
Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RIVS Vascular Access | Time Required to Obtain Access | 4.0 minutes | Standard Deviation 4 |
| Conventional Vascular Access | Time Required to Obtain Access | 5.0 minutes | Standard Deviation 5 |