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

This study has been terminated.
(Funding Stopped)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00914069
First received: June 1, 2009
Last updated: March 2, 2017
Last verified: March 2017
Results First Received: November 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Other
Condition: Vascular Access Complication
Interventions: Device: RIVS vascular access
Device: Conventional vascular access

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    RIVS Vascular Access   Conventional Vascular Access
STARTED   84   88 
COMPLETED   84   88 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   RIVS Vascular Access   Conventional Vascular Access   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   88   172 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 84   88   172 
   66.1  (9.4)   67.2  (10.9)   66.7  (10.2) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 84   86   170 
Female      36  42.9%      49  57.0%      85  50.0% 
Male      48  57.1%      37  43.0%      85  50.0% 
[1] Sex data were missing for two (2) subjects.
Race/Ethnicity, Customized 
[Units: Participants]
     
White       
Participants Analyzed 
[Units: Participants]
 84   88   172 
White   42   44   86 
Black       
Participants Analyzed 
[Units: Participants]
 84   88   172 
Black   10   10   20 
Asian       
Participants Analyzed 
[Units: Participants]
 84   88   172 
Asian   14   16   30 
Hispanic       
Participants Analyzed 
[Units: Participants]
 84   88   172 
Hispanic   10   7   17 
Other       
Participants Analyzed 
[Units: Participants]
 84   88   172 
Other   8   9   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt   [ Time Frame: An access attempt usually ranges from 0 to 45 minutes in duration. ]

2.  Primary:   Summary of Major Complications   [ Time Frame: Post-PIV placement until catheter removal (usually within 4 days) ]

3.  Secondary:   Time Required to Obtain Access   [ Time Frame: An access attempt usually ranges from 0 to 45 minutes in duration. ]

4.  Secondary:   Second Stick Success Rate   [ Time Frame: An access attempt usually ranges from 0 to 45 minutes in duration. ]

5.  Secondary:   Summary of Minor Complications   [ Time Frame: Post-PIV placement until catheter removal (usually within 4 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gina Gilbert
Organization: Bard Access Systems, Inc.
phone: 407-489-0835
e-mail: Gina.Gilbert@crbard.com



Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00914069     History of Changes
Other Study ID Numbers: 62009123
Study First Received: June 1, 2009
Results First Received: November 14, 2016
Last Updated: March 2, 2017