Catheterization, PeripheralNCT01104103

Effectiveness Study of the BOA(R)-Constricting IV Band

A study testing BOA(R)-Constricting IV Band and Standard elastic constricting band in people with Catheterization, Peripheral, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior to standard methods for starting an IV. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Catheterization, Peripheral
What is being tested?: BOA(R)-Constricting IV Band and Standard elastic constricting band
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 467 participants
Where: 2 sitesUnited States
Study dates: Mar 2010to May 2010
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Paramedics employed by the City of Houston or nurses employed by Memorial Hermann Hospital - Texas Medical Center
Agree to participate through written consent process

Who cannot join

City of Houston paramedics and Memorial Hermann Hospital - Texas Medical Center nurses who do not provide written informed consent to participate

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Houston Fire Department
Houston, Texas, 77002
Memorial Hermann Hospital-Texas Medical Center
Houston, Texas, 77030-1501

Other trials in United States

About this study

Official title: The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness

The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior to standard methods for starting an IV.

Read the detailed description

We will test the hypothesis that paramedics and nurses treating in- and out-of-hospital patients with a BOA(R)-Constricting IV Band, compared to paramedics using standard treatment, will have better success rates for peripheral IV access.

Conditions: Catheterization, Peripheral
Being tested: BOA(R)-Constricting IV Band, Standard elastic constricting band
Keywords: Catheterization, Peripheral, Disposable Equipment, Emergency Medical Technicians, Emergency Nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOA(R)-Constricting IV BandDevice
Also called NSN: 6515-01-537-2611
Device applied in accordance with manufacturer's instructions
Standard elastic constricting bandDevice
Also called elastic constricting band (Cardinal Health; McGaw Park, IL)
Standard therapy

Study groups in NCT01104103
Study group	Role	What they receive
BOA(R)	Experimental	Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult Receives: Device: BOA(R)-Constricting IV Band
Standard care	Active comparator	Nurse or paramedic uses standard IV starting technique in the upper extremity of adults Receives: Device: Standard elastic constricting band

What is being measured

The primary outcome is the main question the study is designed to answer.

Success
This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.
Measured: five minutes (average)

Secondary outcomes (1)

First Stick Success
This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.
Measured: Five minutes (average)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010May 2010

First posted15 Apr 2010 (estimated)
Study startMar 2010
Primary completionMay 2010
Study completionMay 2010

Why it stopped: Pre-determined stopping point met with signficant difference between intervention and control groups.

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01104103
Sponsor's protocol ID: NAR UTH 001
Status last verified: Jul 2012
First submitted: 9 Apr 2010
Last updated: 20 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Black KJ, Pusic MV, Harmidy D, McGillivray D. Pediatric intravenous insertion in the emergency department: bevel up or bevel down? Pediatr Emerg Care. 2005 Nov;21(11):707-11. doi: 10.1097/01.pec.0000186422.77140.1f.
PubMed 16280942
Meier J, Schreier E. Human plasma levels of some anti-migraine drugs. Headache. 1976 Jul;16(3):96-104. doi: 10.1111/j.1526-4610.1976.hed1603096.x. No abstract available.
PubMed 965227
Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005 Sep-Oct;34(5):345-59. doi: 10.1016/j.hrtlng.2005.04.002.
PubMed 16157191
Lapostolle F, Catineau J, Garrigue B, Monmarteau V, Houssaye T, Vecci I, Treoux V, Hospital B, Crocheton N, Adnet F. Prospective evaluation of peripheral venous access difficulty in emergency care. Intensive Care Med. 2007 Aug;33(8):1452-7. doi: 10.1007/s00134-007-0634-y. Epub 2007 Jun 7.
PubMed 17554524
Pons PT, Moore EE, Cusick JM, Brunko M, Antuna B, Owens L. Prehospital venous access in an urban paramedic system--a prospective on-scene analysis. J Trauma. 1988 Oct;28(10):1460-3. doi: 10.1097/00005373-198810000-00009.
PubMed 3172305

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety

All Catheterization, Peripheral trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness
ClinicalTrials.gov ID: NCT01104103
Acronym / sponsor ID: NAR UTH 001
Conditions: Catheterization, Peripheral
Keywords: Catheterization, Peripheral, Disposable Equipment, Emergency Medical Technicians, Emergency Nursing
Study type: Interventional
Recruitment status: TerminatedReason stopped: Pre-determined stopping point met with signficant difference between intervention and control groups.
Enrolment: 467 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: North American Rescue, LLC
Study start: Mar 2010
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 15 Apr 2010 (estimated)
Results: Posted 20 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior to standard methods for starting an IV.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BOA(R)	Experimental	Device: BOA(R)-Constricting IV BandNurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
Standard care	Active comparator	Device: Standard elastic constricting bandNurse or paramedic uses standard IV starting technique in the upper extremity of adults

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Paramedics employed by the City of Houston or nurses employed by Memorial Hermann Hospital - Texas Medical Center
Agree to participate through written consent process

Key exclusion criteria (1 listed)

City of Houston paramedics and Memorial Hermann Hospital - Texas Medical Center nurses who do not provide written informed consent to participate

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
BOA(R)-Constricting IV BandAlso: NSN: 6515-01-537-2611Device applied in accordance with manufacturer's instructions	Device	BOA(R)
Standard elastic constricting bandAlso: elastic constricting band (Cardinal Health; McGaw Park, IL)Standard therapy	Device	Standard care

Primary outcome

Success
Time frame: five minutes (average)
This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.

1 secondary outcome

First Stick Success
Time frame: Five minutes (average)

Results and safety

Results posted to the registry on 20 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BOA(R)	243	243
Standard Care	224	224

Primary outcome: Success

Time frame: five minutes (average). Number. Unit: participants

Measure	BOA(R) n = 243	Standard Care n = 224
Value	198	214

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BOA(R)	0 of 243 (0%)	0 of 243 (0%)	Not reported
Standard Care	0 of 224 (0%)	0 of 224 (0%)	Not reported

Limitations and caveats (from the sponsor): There was a significant disparity between subjective opinion and objective results. Nurses and paramedics who used the BOA were uniformly positive in their comments about the device.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16280942Black KJ, Pusic MV, Harmidy D, McGillivray D. Pediatric intravenous insertion in the emergency department: bevel up or bevel down? Pediatr Emerg Care. 2005 Nov;21(11):707-11. doi: 10.1097/01.pec.0000186422.77140.1f.
Background: PubMed 965227Meier J, Schreier E. Human plasma levels of some anti-migraine drugs. Headache. 1976 Jul;16(3):96-104. doi: 10.1111/j.1526-4610.1976.hed1603096.x. No abstract available.
Background: PubMed 16157191Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005 Sep-Oct;34(5):345-59. doi: 10.1016/j.hrtlng.2005.04.002.
Background: PubMed 17554524Lapostolle F, Catineau J, Garrigue B, Monmarteau V, Houssaye T, Vecci I, Treoux V, Hospital B, Crocheton N, Adnet F. Prospective evaluation of peripheral venous access difficulty in emergency care. Intensive Care Med. 2007 Aug;33(8):1452-7. doi: 10.1007/s00134-007-0634-y. Epub 2007 Jun 7.
Background: PubMed 3172305Pons PT, Moore EE, Cusick JM, Brunko M, Antuna B, Owens L. Prehospital venous access in an urban paramedic system--a prospective on-scene analysis. J Trauma. 1988 Oct;28(10):1460-3. doi: 10.1097/00005373-198810000-00009.

Related trials for Catheterization, Peripheral

Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety

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.

Richard N Bradley, M.D. principal investigator

The University of Texas Health Science Center, Houston

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 1 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 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 20 Aug 2012). 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?

Success (time frame: five minutes (average)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01104103, which also lists 5 linked publications.

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 20 Aug 2012.