SurgeryNCT04130022
Premedication Gastric Ultrasound
A study testing Point-of-Care Ultrasound in people with Surgery, run by Kevin Spellman at 1 site in United States.
Trial summary
The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Surgery
- What is being tested?
- Point-of-Care Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to Dec 2027
- Phase
- Interventional
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia.
Who cannot join
- Patients who are not adhere to institutional fasting guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Ultrasound Assessment of Gastric Volume After Drinking Premedication: A Prospective Descriptive Study
The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.
- Conditions
- Surgery
- Being tested
- Point-of-Care Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care UltrasoundDevice
Portable ultrasonography done at the bedside.
| Study group | Role | What they receive |
|---|---|---|
| Fasted Children | Other | Not described Receives: Device: Point-of-Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Qualitative and Quantitative Gastric Assessment After Premedication
Gastric volume in fasted children before and after drinking premedication. Gastric volume in pediatric patients is estimated by the model: GV= -7.8 + (3.5× RLD CSA) + (0.127) × age (months).
Measured: Ultrasound scan performed at baseline (before surgery) to measure gastric volume and 3 minutes after taking premedication to assess change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start18 Aug 2025
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kevin Spellman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin Spellman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130022
- Sponsor's protocol ID
- STUDY00000586
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No