Trial Outcomes & Findings for Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter (NCT NCT00914069)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

An access attempt usually ranges from 0 to 45 minutes in duration.

Results posted on

2017-04-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	RIVS Vascular Access RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Overall Study STARTED	84	88
Overall Study COMPLETED	84	88
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex data were missing for two (2) subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RIVS Vascular Access n=84 Participants RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=88 Participants Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device	Total n=172 Participants Total of all reporting groups
Age, Continuous	66.1 years STANDARD_DEVIATION 9.4 • n=84 Participants	67.2 years STANDARD_DEVIATION 10.9 • n=88 Participants	66.7 years STANDARD_DEVIATION 10.2 • n=172 Participants
Sex: Female, Male Female	36 Participants n=84 Participants • Sex data were missing for two (2) subjects.	49 Participants n=86 Participants • Sex data were missing for two (2) subjects.	85 Participants n=170 Participants • Sex data were missing for two (2) subjects.
Sex: Female, Male Male	48 Participants n=84 Participants • Sex data were missing for two (2) subjects.	37 Participants n=86 Participants • Sex data were missing for two (2) subjects.	85 Participants n=170 Participants • Sex data were missing for two (2) subjects.
Race/Ethnicity, Customized White	42 participants n=84 Participants	44 participants n=88 Participants	86 participants n=172 Participants
Race/Ethnicity, Customized Black	10 participants n=84 Participants	10 participants n=88 Participants	20 participants n=172 Participants
Race/Ethnicity, Customized Asian	14 participants n=84 Participants	16 participants n=88 Participants	30 participants n=172 Participants
Race/Ethnicity, Customized Hispanic	10 participants n=84 Participants	7 participants n=88 Participants	17 participants n=172 Participants
Race/Ethnicity, Customized Other	8 participants n=84 Participants	9 participants n=88 Participants	17 participants n=172 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RIVS Vascular Access n=84 Participants RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=88 Participants Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt	60 participants	51 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RIVS Vascular Access n=84 Participants RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=88 Participants Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Summary of Major Complications	0 participants	0 participants

SECONDARY outcome

Timeframe: An access attempt usually ranges from 0 to 45 minutes in duration.

A secured flushed IV will be indicative of a successful PIV placement.

Outcome measures

Outcome measures
Measure	RIVS Vascular Access n=84 Participants RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=88 Participants Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Time Required to Obtain Access	4.0 minutes Standard Deviation 4.0	5.0 minutes Standard Deviation 5.0

SECONDARY outcome

Timeframe: 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.

A secured flushed IV will be indicative of a successful PIV placement.

Outcome measures

Outcome measures
Measure	RIVS Vascular Access n=23 Participants RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=36 Participants Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Second Stick Success Rate	10 participants	18 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RIVS Vascular Access n=84 Participants RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=88 Participants Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Summary of Minor Complications	1 participants	0 participants

Adverse Events

RIVS Vascular Access

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Conventional Vascular Access

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	RIVS Vascular Access n=84 participants at risk RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional Vascular Access n=88 participants at risk Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Vascular disorders Minor Vasular Complication	1.2% 1/84	0.00% 0/88

Additional Information

Gina Gilbert

Bard Access Systems, Inc.

Phone: 407-489-0835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigators may publish or present the study results with prior consent of the Sponsor, but will not disclose confidential information. Prior to submission by a Principal Investigator for publication or presentation, the Sponsor will be provided with the opportunity to review the submission for confidential information and accuracy.
Publication restrictions are in place

Restriction type: OTHER