SurgeryNCT07722065
Handheld US Device to Verify Vascular Cannulation
A study testing Sonosite and Lumify® in people with Surgery, run by Alok Moharir at 1 site in United States.
Trial summary
This a prospective study in pediatric patients undergoing surgery and requiring placement of an intravenous cannula. This will be a novel study to assess whether a handheld compatible cardiac ultrasound device (Lumify) can be used to quickly and reliably verify successful vascular cannulation in pediatric patients… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Surgery
- What is being tested?
- Sonosite and Lumify®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients ranging in age from 1-6 years
- presenting for surgery and requiring placement of an intravenous cannula.
Who cannot join
- potential subjects that are fluid or sodium sensitive
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: The Use of a Handheld Cardiac Ultrasound Device to Verify Successful Peripheral Vascular Cannulation in Pediatric Patients.
This a prospective study in pediatric patients undergoing surgery and requiring placement of an intravenous cannula. This will be a novel study to assess whether a handheld compatible cardiac ultrasound device (Lumify) can be used to quickly and reliably verify successful vascular cannulation in pediatric patients using the rapid atrial swirl sign (RASS) technique. As emerging technologies have made hand-held ultrasound devices more versatile, portable, and cheaper, it will be important to prove if they can be as accurate as traditional ultrasound devices for their intended focused point-of-care functions. If the handheld device is deemed efficacious, it will allow the use of a portable hand-held device rather than the more difficult to transport devices (Sonosite).
- Conditions
- Surgery
- Being tested
- Sonosite, Lumify®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonositeDevice
A stand alone ultrasound machine with a linear probe.
Lumify®Device
A novel, handheld ultrasound device with a cardiac phase array probe attached to a tablet.
| Study group | Role | What they receive |
|---|---|---|
| Sonosite | Active comparator | Sonosite® ultrasound device with a linear probe. Receives: Device: Sonosite |
| Lumify | Experimental | A novel, handheld ultrasound device with a cardiac phase array probe that is attached to a tablet. Receives: Device: Lumify® |
What is being measured
The primary outcome is the main question the study is designed to answer.
RASS
The ability of a hand held cardiac ultrasound in detecting successful peripheral IV placement using the right atrial swirl sign (RASS) compared to a traditional ultrasound.
Measured: Baseline
Secondary outcomes (1)
Time
The amount of time required to obtain the necessary imaging between the two devices.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start22 Sep 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alok Moharir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alok Moharir, Nationwide Children's Hospital
- Investigators
- Alok Moharir, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722065
- Sponsor's protocol ID
- STUDY00001776
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Handheld Cardiac Ultrasound Device to Verify Successful Peripheral Vascular Cannulation in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT07722065
- Acronym / sponsor ID
- STUDY00001776
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alok MoharirUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (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 a prospective study in pediatric patients undergoing surgery and requiring placement of an intravenous cannula. This will be a novel study to assess whether a handheld compatible cardiac ultrasound device (Lumify) can be used to quickly and reliably verify successful vascular cannulation in pediatric patients using the rapid atrial swirl sign (RASS) technique. As emerging technologies have made hand-held ultrasound devices more versatile, portable, and cheaper, it will be important to prove if they can be as accurate as traditional ultrasound devices for their intended focused point-of-care functions. If the handheld device is deemed efficacious, it will allow the use of a portable hand-held device rather than the more difficult to transport devices (Sonosite).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonosite | Active comparator | Device: SonositeSonosite® ultrasound device with a linear probe. |
| Lumify | Experimental | Device: Lumify®A novel, handheld ultrasound device with a cardiac phase array probe that is attached to a tablet. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric patients ranging in age from 1-6 years
- presenting for surgery and requiring placement of an intravenous cannula.
Key exclusion criteria (1 listed)
- potential subjects that are fluid or sodium sensitive
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 |
|---|---|---|
| SonositeA stand alone ultrasound machine with a linear probe. | Device | Sonosite |
| Lumify®A novel, handheld ultrasound device with a cardiac phase array probe attached to a tablet. | Device | Lumify |
Primary outcome
RASS
Time frame: Baseline
The ability of a hand held cardiac ultrasound in detecting successful peripheral IV placement using the right atrial swirl sign (RASS) compared to a traditional ultrasound.
1 secondary outcome
Time
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- 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.
Alok Moharir, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonosite and Lumify® in people with Surgery, run by Alok Moharir 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 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
RASS (time frame: Baseline). 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 21 Oct 2026.