Venous AccessNCT04234347
Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access
A study testing Intravenous access method in people with Venous Access, run by Temple University at 1 site in United States.
Trial summary
To compare a long axis approach versus short axis when placing peripheral IVs using ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Venous Access
- What is being tested?
- Intravenous access method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Dec 2025
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamically stable patients requiring placement of an USGPIV.
Who cannot join
- Hemodynamically unstable
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
Ryan C Gibbons, MD, 610-613-7408, ryan.gibbons@tuhs.temple.edu
About this study
Official title: Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access: A Randomized Control Trial
To compare a long axis approach versus short axis when placing peripheral IVs using ultrasound guidance.
Read the detailed description
Patients needing an USGPIV will be randomized into long or short axis orientation. Emergency Medicine residents will place the IV using an ultrasound.
- Conditions
- Venous Access
- Being tested
- Intravenous access method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous access methodProcedure or surgery
Comparing long and short axis approach to USGPIV access.
| Study group | Role | What they receive |
|---|---|---|
| Long Axis approach | Active comparator | Utilize the longitudinal orientation when placing an USGPIV. Receives: Procedure: Intravenous access method |
| Short axis approach | Active comparator | Utilize the transverse orientation when placing an USGPIV. Receives: Procedure: Intravenous access method |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success
USGPIV access
Measured: 1 day
Number of attempts
USGPIV access
Measured: 1 day
Overall success
USGPIV access
Measured: 1 day
Time to completion
USGPIV access
Measured: 1 day
Secondary outcomes (1)
Complications
USGPIV access
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 May 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Gibbons, Temple University
- Investigators
- Ryan C Gibbons, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234347
- Sponsor's protocol ID
- 26147
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2020
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
PubMed 36507736
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04234347
- Acronym / sponsor ID
- 26147
- Conditions
- Venous Access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Jan 2020 (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.
To compare a long axis approach versus short axis when placing peripheral IVs using ultrasound guidance.
Detailed description
Patients needing an USGPIV will be randomized into long or short axis orientation. Emergency Medicine residents will place the IV using an ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Axis approach | Active comparator | Procedure: Intravenous access methodUtilize the longitudinal orientation when placing an USGPIV. |
| Short axis approach | Active comparator | Procedure: Intravenous access methodUtilize the transverse orientation when placing an USGPIV. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodynamically stable patients requiring placement of an USGPIV.
Key exclusion criteria (2 listed)
- Hemodynamically unstable
- Unable to consent
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 |
|---|---|---|
| Intravenous access methodComparing long and short axis approach to USGPIV access. | Procedure or surgery | Long Axis approach, Short axis approach |
Primary outcome
First pass success
Time frame: 1 day
USGPIV access
Number of attempts
Time frame: 1 day
USGPIV access
Overall success
Time frame: 1 day
USGPIV access
Time to completion
Time frame: 1 day
USGPIV access
1 secondary outcome
Complications
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 36507736Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
- 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.
Ryan C Gibbons, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous access method in people with Venous Access, run by Temple University at 1 site 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 1 inclusion and 2 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan C Gibbons, MD (6106137408, ryan.gibbons@tuhs.temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success (time frame: 1 day). The study lists 4 primary outcomes in all. 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 NCT04234347, which also lists 1 linked publication.
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 11 Apr 2024.