Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter

• Sponsor: C. R. Bard (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00914069
• Collaborator: (none)
• Enrollment: 175
• Locations: 3
• Arms: 2
• Duration (Months): 50
• Patients Per Site: 58.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Device: RIVS vascular access; Device: Conventional vascular access	N/A

Detailed Description

The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of the Safety and Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter for Peripheral Intravenous (PIV) Insertion in Children, Oncology Patients and Elderly: a Controlled Randomized Trial
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RIVS vascular access RIVS vascular access	Device: RIVS vascular access; Access to peripheral vasculature
Active Comparator: Conventional vascular access Conventional vascular access	Device: Conventional vascular access; Vascular access using conventional venous access device

Outcome Measures

Primary Outcome Measures

1. IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt [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.

2. Summary of Major Complications [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.

Secondary Outcome Measures

1. Time Required to Obtain Access [An access attempt usually ranges from 0 to 45 minutes in duration.]

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

2. Second Stick Success Rate [An access attempt usually ranges from 0 to 45 minutes in duration.]

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

3. Summary of Minor Complications [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years

• Requires peripheral IV as determined by examining physician

• Requires the IV when a study nurse or resident is available

• Able to sign an informed consent

Exclusion Criteria

• Active systemic or cutaneous infection or inflammation;

• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;

• Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);

• Currently involved in any other investigational clinical trials;

• Previous vascular grafts or surgery at the target vessel access site;

• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;

• Central line available

• Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Outpatient Surgery Center	Fremont	California	United States	94538
2	St. Vincent's Medical Center	Jacksonville	Florida	United States	32204
3	University Hospital Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• C. R. Bard

Investigators

• Principal Investigator: Jeffrey S Stuart, MD, Washington Outpatient Surgery Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT00914069
• Other Study ID Numbers: 62009123
• First Posted: Jun 4, 2009
• Last Update Posted: Apr 13, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Period Title: Overall Study
STARTED	84	88
COMPLETED	84	88
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access	Total
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device	Total of all reporting groups
Overall Participants	84	88	172
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.1 (9.4)	67.2 (10.9)	66.7 (10.2)
Sex: Female, Male (Count of Participants)
Female	36 42.9%	49 55.7%	85 49.4%
Male	48 57.1%	37 42%	85 49.4%
Race/Ethnicity, Customized (participants) [Number]
White	42 50%	44 50%	86 50%
Black	10 11.9%	10 11.4%	20 11.6%
Asian	14 16.7%	16 18.2%	30 17.4%
Hispanic	10 11.9%	7 8%	17 9.9%
Other	8 9.5%	9 10.2%	17 9.9%

Outcome Measures

1. Primary Outcome

Title	IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
Description	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.
Time Frame	An access attempt usually ranges from 0 to 45 minutes in duration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Measure Participants	84	88
Number [participants]	60 71.4%	51 58%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RIVS Vascular Access, Conventional Vascular Access
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Summary of Major Complications
Description	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.
Time Frame	Post-PIV placement until catheter removal (usually within 4 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Measure Participants	84	88
Number [participants]	0 0%	0 0%

3. Secondary Outcome

Title	Time Required to Obtain Access
Description	A secured flushed IV will be indicative of a successful PIV placement.
Time Frame	An access attempt usually ranges from 0 to 45 minutes in duration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Measure Participants	84	88
Mean (Standard Deviation) [minutes]	4.0 (4.0)	5.0 (5.0)

4. Secondary Outcome

Title	Second Stick Success Rate
Description	A secured flushed IV will be indicative of a successful PIV placement.
Time Frame	An access attempt usually ranges from 0 to 45 minutes in duration.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Measure Participants	23	36
Number [participants]	10 11.9%	18 20.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RIVS Vascular Access, Conventional Vascular Access
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Summary of Minor Complications
Description	Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.
Time Frame	Post-PIV placement until catheter removal (usually within 4 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RIVS Vascular Access	Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature	Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
Measure Participants	84	88
Number [participants]	1 1.2%	0 0%

Adverse Events

Arm/Group Title	RIVS Vascular Access		Conventional Vascular Access
Arm/Group Description	RIVS vascular access RIVS vascular access: Access to peripheral vasculature		Conventional vascular access Conventional vascular access: Vascular access using conventional venous access device
All Cause Mortality
	RIVS Vascular Access		Conventional Vascular Access
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	RIVS Vascular Access		Conventional Vascular Access
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/88 (0%)
Other (Not Including Serious) Adverse Events
	RIVS Vascular Access		Conventional Vascular Access
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/84 (1.2%)		0/88 (0%)
Vascular disorders
Minor Vasular Complication	1/84 (1.2%)		0/88 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.