Trial Outcomes & Findings for Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy (NCT NCT04048863)

Last Updated: 2022-08-01

Results Overview

\[Planned\] 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.

Recruitment status

TERMINATED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

Through study completion, an estimate of 1 year

Results posted on

2022-08-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Stage 1 Baseline Study site to use standard of care PIVC device(s) and procedure(s) on patients. For this study, PARTICIPANTS were defined as patients whom the procedures were performed on; RNs were the individuals performing the procedures. Hospital Standard of Care: Standard of Care for PIVC access per hospital protocol	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 \\THIS PHASE WAS NOT CONDUCTED\\	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 \\THIS PHASE WAS NOT CONDUCTED\\	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 \\THIS PHASE WAS NOT CONDUCTED\\
Overall Study STARTED	43	0	0	0
Overall Study COMPLETED	43	0	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1 Baseline n=44 Participants 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	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	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	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	Total n=44 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 16.15 • n=5 Participants	—	—	—	69.2 years STANDARD_DEVIATION 16.15 • n=21 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	—	—	—	27 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	—	—	—	17 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	—	—	—	44 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	—	—	—	44 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Region of Enrollment United States	44 participants n=5 Participants	—	—	—	44 participants n=21 Participants
BMI	31.9 kg/m^2 STANDARD_DEVIATION 9.47 • n=5 Participants	—	—	—	31.9 kg/m^2 STANDARD_DEVIATION 9.47 • n=21 Participants

PRIMARY outcome

Timeframe: Through study completion, an estimate of 1 year

Population: Study stopped due to recruitment futility. Stages 2 through 4 were not conducted.

Outcome measures

Outcome measures
Measure	Stage 1 Baseline n=57 Stick Attempts 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	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	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	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
Complications Associated With PIVC Use	22 Stick Attempts	—	—	—

SECONDARY outcome

Timeframe: 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.

Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion.

Outcome measures

Outcome measures
Measure	Stage 1 Baseline n=35 Participants 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	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	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	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
Catheter Indwell Time < 48 hours	25.00 Hours Interval 2.37 to 47.68	—	—	—
Catheter Indwell Time >= 48 hours	76.84 Hours Interval 48.42 to 211.35	—	—	—

SECONDARY outcome

Timeframe: Initial needle stick (baseline)

Population: Study stopped due to recruitment futility. Stages 2 through 4 were not conducted.

Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion.

Outcome measures

Outcome measures
Measure	Stage 1 Baseline n=57 Stick Attempts 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	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	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	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
First Attempt Success Rates (First Stick Success)	28 Stick Attempts	—	—	—

SECONDARY outcome

Timeframe: 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.

Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion.

Outcome measures

Outcome data not reported

Adverse Events

Stage 1 Baseline

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Stage 2 Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 3 Run-In

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 4 Post-Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stage 1 Baseline n=43 participants at risk 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	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	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	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
General disorders Infiltration	9.3% 4/43 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.
Product Issues Occlusion	7.0% 3/43 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.
Surgical and medical procedures Accidental Removal	9.3% 4/43 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.
Vascular disorders Phlebitis	2.3% 1/43 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.	— 0/0 • Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported). Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.

Additional Information

Dr. Diana Valencia

B. Braun Medical Inc.

Phone: 610-596-2875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications and redact proprietary information prior to public release and can embargo communications regarding trial results for a period of at least 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes (other than as described) to the communication however the embargo may be extended an additional 60 days if patent issues are involved.
Publication restrictions are in place

Restriction type: OTHER