Intravenous AccessNCT04875988
Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport
A study testing Butterfly iQ+ Ultrasound and Traditional in people with Intravenous Access, run by Arkansas Children's Hospital Research Institute.
Trial summary
This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Access
- What is being tested?
- Butterfly iQ+ Ultrasound and Traditional
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 weeks to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients requiring IV access prior to transport by the Angel One Transport Team back to Arkansas Children's Hospital
- Age group: 2 weeks - 18 years
Who cannot join
- Adequate IV Access
- NICU transports
- Patients not needing IV access
Trial locations and contacts
No sites are listed yet.
About this study
This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. We will examine and compare first attempt success rates with each method.
- Conditions
- Intravenous Access
- Being tested
- Butterfly iQ+ Ultrasound, Traditional
- Keywords
- pediatrics, interfacility transport, intravenous access, ultrasound, POCUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly iQ+ UltrasoundProcedure or surgery
ultrasound will be used in the intervention group for IV access
TraditionalProcedure or surgery
ultrasound will not be used in the traditional IV placement group
| Study group | Role | What they receive |
|---|---|---|
| POCUS-assisted IV placement | Active comparator | using ultrasound to help with placement Receives: Procedure: Butterfly iQ+ Ultrasound |
| Traditional IV placement | Active comparator | Standard of care Receives: Procedure: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt IV success rates
Measured: 1 day of transfer
Secondary outcomes (1)
Beside Times during transport
as reported (in minutes)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous AccessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Stroud, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875988
- Sponsor's protocol ID
- 262598
- Status last verified
- Oct 2021
- First submitted
- 3 May 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport
- ClinicalTrials.gov ID
- NCT04875988
- Acronym / sponsor ID
- 262598
- Conditions
- Intravenous Access
- Keywords
- pediatrics, interfacility transport, intravenous access, ultrasound, POCUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. We will examine and compare first attempt success rates with each method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS-assisted IV placement | Active comparator | Procedure: Butterfly iQ+ Ultrasoundusing ultrasound to help with placement |
| Traditional IV placement | Active comparator | Procedure: TraditionalStandard of care |
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric patients requiring IV access prior to transport by the Angel One Transport Team back to Arkansas Children's Hospital
- Age group: 2 weeks - 18 years
Key exclusion criteria (3 listed)
- Adequate IV Access
- NICU transports
- Patients not needing IV access
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 |
|---|---|---|
| Butterfly iQ+ Ultrasoundultrasound will be used in the intervention group for IV access | Procedure or surgery | POCUS-assisted IV placement |
| Traditionalultrasound will not be used in the traditional IV placement group | Procedure or surgery | Traditional IV placement |
Primary outcome
First Attempt IV success rates
Time frame: 1 day of transfer
1 secondary outcome
Beside Times during transport
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Michael H Stroud, MD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly iQ+ Ultrasound and Traditional in people with Intravenous Access, run by Arkansas Children's Hospital Research Institute.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael H Stroud, MD (501-364-1861, StroudMichaelH@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt IV success rates (time frame: 1 day of transfer). 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 15 Oct 2021.