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

• Sponsor: B. Braun Medical Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04048863
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 4
• Actual Duration (Months): 18.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complications Associated With Device	Device: B. Braun Peripheral Advantage (PA) Program; Device: Hospital Standard of Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
• Actual Study Start Date: Jan 24, 2020
• Actual Primary Completion Date: Jul 27, 2021
• Actual Study Completion Date: Jul 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stage 1 Baseline Study site to use standard of care PIVC device(s) and procedure(s) on patients.	Device: Hospital Standard of Care; Standard of Care for PIVC access per hospital protocol
Other: Stage 2 Education RN education and training in the use of B. Braun PIVC products, devices and procedures.	Device: 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
Other: Stage 3 Run-In Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting.	Device: 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
Other: Stage 4 Post-Education Study site uses B. Braun PIVC device(s) and procedure(s) on patients.	Device: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 Exclusion Criteria:

1. Are currently participating in another medical device or pharmaceutical study;

2. In the opinion of the Investigator, would not be suitable candidates for this study;

3. The subject or his/her LAR is an employee of the Investigator or study center, or the sponsor, or have direct involvement in the study or other studies under the direction of that Investigator or study center, or are a family member of the employees or the Investigator;

4. Have a laboratory confirmed bloodstream infection within 48 hours prior to participation in the study. The assessment is based on clinical observations and not routine for all subjects;

5. Patient has an existing non study related IV;

6. Was removed from any Stage of the study due to an AE associated with the PIVC.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

• B. Braun Medical Inc.

Investigators

• Principal Investigator: Camilla M Jaekel, RN, Mayo Clinic - La Crosse, WI

Study Documents (Full-Text)

• Study Protocol - Feb 3, 2021
• Statistical Analysis Plan - Dec 3, 2021

More Information

Publications

None provided.

• Responsible Party: B. Braun Medical Inc.
• ClinicalTrials.gov Identifier: NCT04048863
• Other Study ID Numbers: US-N-H-1801
• First Posted: Aug 7, 2019
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Imidacloprid

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Stage 1 Baseline	Stage 2 Education	Stage 3 Run-In	Stage 4 Post-Education
Arm/Group Description	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	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**	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**	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**
Period Title: Overall Study
STARTED	43	0	0	0
COMPLETED	43	0	0	0
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Stage 1 Baseline	Stage 2 Education	Stage 3 Run-In	Stage 4 Post-Education	Total
Arm/Group Description	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	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	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	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 of all reporting groups
Overall Participants	44	0	0	0	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (16.15)	69.2 (16.15)
Sex: Female, Male (Count of Participants)
Female	27 61.4%	27 Infinity
Male	17 38.6%	17 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN
Not Hispanic or Latino	44 100%	44 Infinity
Unknown or Not Reported	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	0 0%	0 NaN
White	44 100%	44 Infinity
More than one race	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	44 100%	44 Infinity
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.9 (9.47)	31.9 (9.47)

Outcome Measures

1. Primary Outcome

Title	Complications Associated With PIVC Use
Description	[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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Stage 1 Baseline	Stage 2 Education	Stage 3 Run-In	Stage 4 Post-Education
Arm/Group Description	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	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	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	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
Measure Participants	43	0	0	0
Measure Stick Attempts	57	0	0	0
Count of Units [Stick Attempts]	22

2. Secondary Outcome

Title	Catheter Indwell Time
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Stage 1 Baseline	Stage 2 Education	Stage 3 Run-In	Stage 4 Post-Education
Arm/Group Description	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	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	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	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
Measure Participants	35	0	0	0
< 48 hours	25.00
>= 48 hours	76.84

3. Secondary Outcome

Title	First Attempt Success Rates (First Stick Success)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Stage 1 Baseline	Stage 2 Education	Stage 3 Run-In	Stage 4 Post-Education
Arm/Group Description	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	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	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	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
Measure Participants	43	0	0	0
Measure Stick Attempts	57	0	0	0
Count of Units [Stick Attempts]	28

4. Secondary Outcome

Title	Aggregate Costs Associated With Catheter Insertion
Description	Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion.
Time Frame	Through study completion, an estimate of 1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Stage 1 Baseline	Stage 2 Education	Stage 3 Run-In	Stage 4 Post-Education
Arm/Group Description	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	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	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	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
Measure Participants	0	0	0	0

Adverse Events

Time Frame	Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported).
Adverse Event Reporting Description	Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.
Arm/Group Title	Stage 1 Baseline		Stage 2 Education		Stage 3 Run-In		Stage 4 Post-Education
Arm/Group Description	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		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		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		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
All Cause Mortality
	Stage 1 Baseline		Stage 2 Education		Stage 3 Run-In		Stage 4 Post-Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Stage 1 Baseline		Stage 2 Education		Stage 3 Run-In		Stage 4 Post-Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Stage 1 Baseline		Stage 2 Education		Stage 3 Run-In		Stage 4 Post-Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/43 (27.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
General disorders
Infiltration	4/43 (9.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Product Issues
Occlusion	3/43 (7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Surgical and medical procedures
Accidental Removal	4/43 (9.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Vascular disorders
Phlebitis	1/43 (2.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Due to limitations in the data collected only in Stage 1, no conclusions can be drawn on the impact of B. Braun PA Program on the incidence of complications associated with PIVC use.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.