Vascular Access Complications
Conditions
Keywords
IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter Study, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance
Brief summary
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
Detailed description
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.
Interventions
DEVICEAccuCath IV Catheter System
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
DEVICEConventional IV Catheter System
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: 1. Male or female, age \> or equal to 18 years or \< or equal to 89 years old; 2. Capable and willing to give informed consent; 3. English speaking; 4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician; 5. Admitted to study area.
Exclusion criteria
1. Male or female, \< 18 years old or \> 89 years old; 2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement); 3. Previous venous grafts or surgery at the target vessel access site; 4. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement | Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Upon Successful PIV Placement | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes | Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable |
| Clinician Satisfaction Upon Successful PIV Placement | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes | Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: How easy was the AccuCath™ System to use in comparison to the current catheter? 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use 1 - Very Difficult to Use |
Countries
United States
Participant flow
Recruitment details
Enrollment occurred from April 2013 - November 2013. Location was Interventional Radiology Department at participating hospital.
Participants by arm
| Arm | Count |
|---|---|
| Vascular Access Via Study Device AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. | 110 |
| Vascular Access Via Control Device Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples | 110 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Vascular Access Via Study Device | Vascular Access Via Control Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 39 Participants | 68 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 71 Participants | 152 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 28 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 73 Participants | 70 Participants | 143 Participants |
| Region of Enrollment United States | 110 participants | 110 participants | 220 participants |
| Sex: Female, Male Female | 47 Participants | 34 Participants | 81 Participants |
| Sex: Female, Male Male | 63 Participants | 76 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 110 |
| other Total, other adverse events | 2 / 110 | 10 / 110 |
| serious Total, serious adverse events | 0 / 110 | 0 / 110 |
Outcome results
Primary
First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
Time frame: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vascular Access Via Study Device | First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement | 84 Participants |
| Vascular Access Via Control Device | First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement | 90 Participants |
Secondary
Clinician Satisfaction Upon Successful PIV Placement
Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: How easy was the AccuCath™ System to use in comparison to the current catheter? 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use 1 - Very Difficult to Use
Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Population: The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 5 in Study Device arm and n = 1 in the Control Arm).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vascular Access Via Study Device | Clinician Satisfaction Upon Successful PIV Placement | 3.27 units on a scale | Standard Deviation 1.11 |
| Vascular Access Via Control Device | Clinician Satisfaction Upon Successful PIV Placement | 3.48 units on a scale | Standard Deviation 1.04 |
Secondary
Patient Satisfaction Upon Successful PIV Placement
Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable
Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Population: The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 6 in Study Device arm and n = 1 in the Control Arm).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vascular Access Via Study Device | Patient Satisfaction Upon Successful PIV Placement | 3.88 units on a scale | Standard Deviation 1.11 |
| Vascular Access Via Control Device | Patient Satisfaction Upon Successful PIV Placement | 4.46 units on a scale | Standard Deviation 0.95 |