Vascular Access ComplicationNCT00914069
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
A study testing RIVS vascular access and Conventional vascular access in people with Vascular Access Complication, run by C. R. Bard at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- RIVS vascular access and Conventional vascular access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospital Case Medical Center
Cleveland, Ohio, 44106
Washington Outpatient Surgery Center
Fremont, California, 94538
St. Vincent's Medical Center
Jacksonville, Florida, 32204
About this study
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
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.
Read the 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.
- Conditions
- Vascular Access Complication
- Being tested
- RIVS vascular access, Conventional vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIVS vascular accessDevice
Access to peripheral vasculature
Conventional vascular accessDevice
Vascular access using conventional venous access device
| Study group | Role | What they receive |
|---|---|---|
| RIVS vascular access | Experimental | RIVS vascular access Receives: Device: RIVS vascular access |
| Conventional vascular access | Active comparator | Conventional vascular access Receives: Device: Conventional vascular access |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
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.
Measured: An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Major Complications
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.
Measured: Post-PIV placement until catheter removal (usually within 4 days)
Secondary outcomes (3)
Time Required to Obtain Access
A secured flushed IV will be indicative of a successful PIV placement.
Measured: An access attempt usually ranges from 0 to 45 minutes in duration.
Second Stick Success Rate
A secured flushed IV will be indicative of a successful PIV placement.
Measured: An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Minor Complications
Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.
Measured: Post-PIV placement until catheter removal (usually within 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionAug 2013
Why it stopped: Funding Stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Stuart, MD, Principal investigator, Washington Outpatient Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914069
- Sponsor's protocol ID
- 62009123
- Status last verified
- Mar 2017
- First submitted
- 1 Jun 2009
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00914069
- Acronym / sponsor ID
- 62009123
- Conditions
- Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Stopped
- Enrolment
- 175 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 13 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIVS vascular access | Experimental | Device: RIVS vascular accessRIVS vascular access |
| Conventional vascular access | Active comparator | Device: Conventional vascular accessConventional vascular access |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIVS vascular accessAccess to peripheral vasculature | Device | RIVS vascular access |
| Conventional vascular accessVascular access using conventional venous access device | Device | Conventional vascular access |
Primary outcome
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.
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.
Summary of Major Complications
Time frame: 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.
3 secondary outcomes
Time Required to Obtain Access
Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.
Second Stick Success Rate
Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Minor Complications
Time frame: Post-PIV placement until catheter removal (usually within 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vascular Access Complication
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
RecruitingObservational study
Mobilisation After Endovascular Stroke Treatment
Stroke, Acute Ischemic Stroke
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S Stuart, MD principal investigator
Washington Outpatient Surgery Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIVS vascular access and Conventional vascular access in people with Vascular Access Complication, run by C. R. Bard at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.