Complications Associated With Device
Conditions
Brief summary
Single sequence clinical study designed to evaluate the effectiveness of B. Braun PA on improved clinical outcomes, indwell time and first stick success of PIVC using B. Braun Peripheral Advantage (PA) by Registered Nurses (RNs). The study will be conducted in the Emergency Department (ED) and/or Medical Surgical (MS) floor(s)/unit(s) in multiple hospitals.
Interventions
DEVICEB. Braun Peripheral Advantage (PA) Program
B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education
Standard of Care for PIVC access per hospital protocol
Sponsors
B. Braun Medical Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* RNs must complete all of the required B. Braun trainings in Stage 2 in order to participate in Stages 3 and 4. Subjects must meet all of the following Inclusion Criteria: 1. Male or female aged ≥18 years; 2. The subject or the subject's LAR voluntarily agrees that the subject will participate in this study and is able to understand and sign the Informed Consent Form (ICF); 3. Have a medical condition that requires a PIVC anticipated to last for at least 48 hours; 4. Have intact skin at the site of insertion; 5. If the patient has an existing IV in one arm he/she must have a viable contralateral arm for additional PIVC insertion.
Exclusion criteria
Subjects must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications Associated With PIVC Use | Through study completion, an estimate of 1 year | \[Planned\] Outcome: Evaluate the impact of B. Braun Peripheral Advantage (PA) Program on the number of stick attempts with complications associated with PIVC use. Due to the early termination in Stage 1, no data were collected from Stages 2 through 4 to perform comparative analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Indwell Time | Up to 48 hours and between 48 and 168 hours | Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion. |
| First Attempt Success Rates (First Stick Success) | Initial needle stick (baseline) | Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion. |
| Aggregate Costs Associated With Catheter Insertion | Through study completion, an estimate of 1 year | Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion. |
Countries
United States
Participant flow
Pre-assignment details
Study was terminated during Stage 1 for recruitment futility. Stages 2 through 4 were not conducted. 44 subjects (patients) were consented in Stage 1, however one subject failed inclusion/exclusion criteria. Thus 43 subjects received study procedures.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 Baseline Study site to use standard of care PIVC device(s) and procedure(s) on patients.
Hospital Standard of Care: Standard of Care for PIVC access per hospital protocol | 44 |
| Stage 2 Education RN education and training in the use of B. Braun PIVC products, devices and procedures.
B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education | 0 |
| Stage 3 Run-In Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting.
B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education | 0 |
| Stage 4 Post-Education Study site uses B. Braun PIVC device(s) and procedure(s) on patients.
B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education | 0 |
| Total | 44 |
Baseline characteristics
| Characteristic | Stage 1 Baseline | Total |
|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 16.15 | 69.2 years STANDARD_DEVIATION 16.15 |
| BMI | 31.9 kg/m^2 STANDARD_DEVIATION 9.47 | 31.9 kg/m^2 STANDARD_DEVIATION 9.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 44 Participants |
| Region of Enrollment United States | 44 participants | 44 participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 12 / 43 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 43 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Complications Associated With PIVC Use
\[Planned\] Outcome: Evaluate the impact of B. Braun Peripheral Advantage (PA) Program on the number of stick attempts with complications associated with PIVC use. Due to the early termination in Stage 1, no data were collected from Stages 2 through 4 to perform comparative analyses.
Time frame: Through study completion, an estimate of 1 year
Population: Study stopped due to recruitment futility. Stages 2 through 4 were not conducted.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Stage 1 Baseline | Complications Associated With PIVC Use | 22 Stick Attempts |
Secondary
Aggregate Costs Associated With Catheter Insertion
Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion.
Time frame: Through study completion, an estimate of 1 year
Population: Data were not collected for this Outcome Measure as a consequence of not performing the assessment. Study stopped during Stage 1 due to recruitment futility.
Secondary
Catheter Indwell Time
Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion.
Time frame: Up to 48 hours and between 48 and 168 hours
Population: Study stopped due to recruitment futility. Stages 2 through 4 were not conducted.~Of the 43 patients with attempted needle sticks, only 35 were successful.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1 Baseline | Catheter Indwell Time | < 48 hours | 25.00 Hours |
| Stage 1 Baseline | Catheter Indwell Time | >= 48 hours | 76.84 Hours |
Secondary
First Attempt Success Rates (First Stick Success)
Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion.
Time frame: Initial needle stick (baseline)
Population: Study stopped due to recruitment futility. Stages 2 through 4 were not conducted.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Stage 1 Baseline | First Attempt Success Rates (First Stick Success) | 28 Stick Attempts |