SurgeryNCT04127331
Gastric Ultrasound
A study testing Point-of-Care Ultrasound in people with Surgery, run by Alok Moharir at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric… Read more about this study
- Who is it for?
- Ages 2 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
- 10 Jan 2020to 6 Sep 2022
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.
Who cannot join
- History of upper gastro-intestinal surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children
The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.
- 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 |
|---|---|---|
| Routine | Active comparator | Patients who are scheduled for routine outpatient surgery. Receives: Device: Point-of-Care Ultrasound |
| Urgent | Active comparator | Patients who are scheduled for urgent surgery. Receives: Device: Point-of-Care Ultrasound |
| Emergent | Active comparator | Patients who are scheduled for emergency surgery. Receives: Device: Point-of-Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration Risk Grade
Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration)
Measured: Baseline
Secondary outcomes (3)
NPO at the Time of Injury
Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups.
Measured: Baseline
NPO at the Time of Surgery
Amount of time the patient was without food or water prior to their surgery.
Measured: Baseline
Pre-operative Opioid Administration
Patients who received opioids for pain control prior to surgery.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start10 Jan 2020
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127331
- Sponsor's protocol ID
- STUDY00000480
- Status last verified
- Feb 2023
- First submitted
- 14 Oct 2019
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children
- ClinicalTrials.gov ID
- NCT04127331
- Acronym / sponsor ID
- STUDY00000480
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alok MoharirUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine | Active comparator | Device: Point-of-Care UltrasoundPatients who are scheduled for routine outpatient surgery. |
| Urgent | Active comparator | Device: Point-of-Care UltrasoundPatients who are scheduled for urgent surgery. |
| Emergent | Active comparator | Device: Point-of-Care UltrasoundPatients who are scheduled for emergency surgery. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.
Key exclusion criteria (1 listed)
- History of upper gastro-intestinal surgery.
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 |
|---|---|---|
| Point-of-Care UltrasoundPortable ultrasonography done at the bedside. | Device | Emergent, Routine, Urgent |
Primary outcome
Aspiration Risk Grade
Time frame: Baseline
Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration)
3 secondary outcomes
NPO at the Time of Injury
Time frame: Baseline
NPO at the Time of Surgery
Time frame: Baseline
Pre-operative Opioid Administration
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-Care Ultrasound 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 1 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: finished, as of the sponsor's last update on 21 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2023). 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?
Aspiration Risk Grade (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 Nov 2023.