ObesityNCT07310875
Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery
A study testing Gastric Point of Care Ultrasound in people with Obesity and Weight Loss, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity, Weight Loss, Gastrectomy
- What is being tested?
- Gastric Point of Care Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to 30 Dec 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years old
- scheduled to undergo bariatric surgery
- no prior abdominal surgery
Who cannot join
- ASA physical status > 3
- Urgent or emergent surgery
- Patient refusal or inability to consent
- Prior abdominal surgery
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
Mount Sinai West and Morningside
New York, New York, 10025
Diane C Armenta, MD, MS, 845-260-0573, Diane.Armenta@mountsinai.org
Malikah Latmore, MD, 917-364-3377, Malikah.Latmore@mountsinai.org
About this study
This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care ultrasound (POCUS). The pre-operative imaging will be done post-intubation and the post-operative imaging will be done pre-extubation. There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under general anesthesia at the time of imaging.
Read the detailed description
Aspiration of gastric contents in the perioperative period is a well-known complication with potentially disastrous consequences. Gastric POCUS is a tool clinicians can utilize to assess stomach fullness and risk stratify prior to induction of anesthesia. There is currently no literature describing how bariatric surgeries impact the location of the stomach and/or the ability of clinicians to obtain gastric POCUS images. Recent increased use of GLP-1 agonists, which delay gastric emptying, has renewed conversations surrounding using gastric POCUS to assess aspiration risk. Case reports have been published showing aspiration events in patients taking GLP-1 agonists despite an adequate fasting period. Additionally, recent studies have shown that these medications can help patients who have undergone bariatric surgery and then regained the weight, lose said weight. Given the possibility that patients may be post-bariatric surgery and currently taking GLP-1 agonists, POCUS is an important skill to utilize that can help anesthesiologists assess aspiration risk. This study will aim to fill a gap in the literature by describing how bariatric surgery can impact the location of the stomach and how to obtain sonographic images of the stomach in a post-bariatric surgery abdomen. The analysis will include description of how the images were obtained (ex: needing to rotate the probe further than expected, or stomach displacement, etc.) and comparison to the procedure used to obtain preoperative images. The measurements will be subjective to the PI who is certified in POCUS use.
Discussions will be held with surgeons who perform bariatric surgery, to determine which patients fit the qualifications to participate in the study. Patients are routinely seen by anesthesiologists for their anesthetic evaluation in the pre-operative holding area on the day of their procedure. After the patient have been evaluated, the patient will have time to discuss the study with the anesthesia team prior to transferring the patient to the OR. Consent will be obtained in the preoperative holding area. There are sequestered rooms in this area where patients can be brought for increased privacy during the consent process. The team will finalize participation and ask the participant to sign the study consent forms. All patient will be provided with copies of the IRB protocol and consent if the patient wish to have it. If agreeable to joining the study, the patient will undergo gastric POCUS after intubation. To perform the gastric POCUS, the patient will be in the supine position and the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient just below the xiphoid. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. The POCUS of the abdomen before abdominal surgery will be done before the surgical team has prepared a sterile field for their surgery. Therefore, there is no need to maintain sterile precautions when using the ultrasound on the abdomen. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS before extubation.
- Conditions
- Obesity, Weight Loss, Gastrectomy
- Being tested
- Gastric Point of Care Ultrasound
- Keywords
- Point of Care Ultrasound, Sleeve gastrectomy
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Point of Care UltrasoundProcedure or surgery
After the patient has undergone intubation, the patient will be positioned in the supine and then the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient below the xiphoid process. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. After the images are obtained, the patient will be repositioned to supine for the procedure. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS prior to extubation.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Point of Care Ultrasound (POCUS) group | Experimental | Participates scheduled to undergo bariatric surgery and have had no prior abdominal surgery. Receives: Procedure: Gastric Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distance from peritoneal wall
Range: 3-5 cm. Higher score indicates greater displacement and less utility of gastric point-of-care ultrasound in these patients.
Measured: end of the individual's procedure, at 2 hrs after procedure start on postoperative day 0
Gastric antrum Cross-sectional area (CSA)
Range: 1-10 centimeters squared. Gastric antrum Cross-sectional area (CSA) is a calculated product of Anteroposterior (AP) Diameter and Craniocaudal (CC) diameter. (CSA = AP x CC) Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
Measured: end of the individual's procedure, at 2 hrs after procedure start
Secondary outcomes (3)
Anteroposterior (AP) Diameter
Range: 0-10 centimeters. Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
Measured: end of the individual's procedure, at 2 hrs after procedure start
Craniocaudal (CC) diameter
Range: 0-10 centimeters. Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
Measured: end of the individual's procedure, at 2 hrs after procedure start
Postoperative aspiration events
Number of Postoperative aspiration events
Measured: until day of hospital discharge, average 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startDec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malikah Latmore, Icahn School of Medicine at Mount Sinai
- Investigators
- Malikah Latmore, MD, Principal investigator, Mount Sinai Morningside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310875
- Sponsor's protocol ID
- STUDY-23-01595
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Pai SL, Bojaxhi E, Logvinov II, Porter SB, Feinglass NG, Robards CB, Torp KD. Ultrasound Assessment of Gastric Volume After Bariatric Surgery: A Case Report. A A Pract. 2019 Jan 1;12(1):1-4. doi: 10.1213/XAA.0000000000000824.
PubMed 29985844Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.
PubMed 12768174Gulak MA, Murphy P. Regurgitation under anesthesia in a fasted patient prescribed semaglutide for weight loss: a case report. Can J Anaesth. 2023 Aug;70(8):1397-1400. doi: 10.1007/s12630-023-02521-3. Epub 2023 Jun 6.
PubMed 37280458
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07310875
- Acronym / sponsor ID
- STUDY-23-01595
- Conditions
- Obesity, Weight Loss, Gastrectomy
- Keywords
- Point of Care Ultrasound, Sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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 is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care ultrasound (POCUS). The pre-operative imaging will be done post-intubation and the post-operative imaging will be done pre-extubation. There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under general anesthesia at the time of imaging.
Detailed description
Aspiration of gastric contents in the perioperative period is a well-known complication with potentially disastrous consequences. Gastric POCUS is a tool clinicians can utilize to assess stomach fullness and risk stratify prior to induction of anesthesia. There is currently no literature describing how bariatric surgeries impact the location of the stomach and/or the ability of clinicians to obtain gastric POCUS images. Recent increased use of GLP-1 agonists, which delay gastric emptying, has renewed conversations surrounding using gastric POCUS to assess aspiration risk. Case reports have been published showing aspiration events in patients taking GLP-1 agonists despite an adequate fasting period. Additionally, recent studies have shown that these medications can help patients who have undergone bariatric surgery and then regained the weight, lose said weight. Given the possibility that patients may be post-bariatric surgery and currently taking GLP-1 agonists, POCUS is an important skill to utilize that can help anesthesiologists assess aspiration risk. This study will aim to fill a gap in the literature by describing how bariatric surgery can impact the location of the stomach and how to obtain sonographic images of the stomach in a post-bariatric surgery abdomen. The analysis will include description of how the images were obtained (ex: needing to rotate the probe further than expected, or stomach displacement, etc.) and comparison to the procedure used to obtain preoperative images. The measurements will be subjective to the PI who is certified in POCUS use.
Discussions will be held with surgeons who perform bariatric surgery, to determine which patients fit the qualifications to participate in the study. Patients are routinely seen by anesthesiologists for their anesthetic evaluation in the pre-operative holding area on the day of their procedure. After the patient have been evaluated, the patient will have time to discuss the study with the anesthesia team prior to transferring the patient to the OR. Consent will be obtained in the preoperative holding area. There are sequestered rooms in this area where patients can be brought for increased privacy during the consent process. The team will finalize participation and ask the participant to sign the study consent forms. All patient will be provided with copies of the IRB protocol and consent if the patient wish to have it. If agreeable to joining the study, the patient will undergo gastric POCUS after intubation. To perform the gastric POCUS, the patient will be in the supine position and the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient just below the xiphoid. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. The POCUS of the abdomen before abdominal surgery will be done before the surgical team has prepared a sterile field for their surgery. Therefore, there is no need to maintain sterile precautions when using the ultrasound on the abdomen. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS before extubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Point of Care Ultrasound (POCUS) group | Experimental | Procedure: Gastric Point of Care UltrasoundParticipates scheduled to undergo bariatric surgery and have had no prior abdominal surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-85 years old
- scheduled to undergo bariatric surgery
- no prior abdominal surgery
Key exclusion criteria (4 listed)
- ASA physical status > 3
- Urgent or emergent surgery
- Patient refusal or inability to consent
- Prior abdominal 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 |
|---|---|---|
| Gastric Point of Care UltrasoundAfter the patient has undergone intubation, the patient will be positioned in the supine and then the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient below the xiphoid process. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. After the images are obtained, the patient will be repositioned to supine for the procedure. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS prior to extubation. | Procedure or surgery | Gastric Point of Care Ultrasound (POCUS) group |
Primary outcome
Change in distance from peritoneal wall
Time frame: end of the individual's procedure, at 2 hrs after procedure start on postoperative day 0
Range: 3-5 cm. Higher score indicates greater displacement and less utility of gastric point-of-care ultrasound in these patients.
Gastric antrum Cross-sectional area (CSA)
Time frame: end of the individual's procedure, at 2 hrs after procedure start
Range: 1-10 centimeters squared. Gastric antrum Cross-sectional area (CSA) is a calculated product of Anteroposterior (AP) Diameter and Craniocaudal (CC) diameter. (CSA = AP x CC) Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
3 secondary outcomes
Anteroposterior (AP) Diameter
Time frame: end of the individual's procedure, at 2 hrs after procedure start
Craniocaudal (CC) diameter
Time frame: end of the individual's procedure, at 2 hrs after procedure start
Postoperative aspiration events
Time frame: until day of hospital discharge, average 1-3 days
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 30 Dec 2025.
- Background: PubMed 29985844Pai SL, Bojaxhi E, Logvinov II, Porter SB, Feinglass NG, Robards CB, Torp KD. Ultrasound Assessment of Gastric Volume After Bariatric Surgery: A Case Report. A A Pract. 2019 Jan 1;12(1):1-4. doi: 10.1213/XAA.0000000000000824.
- Background: PubMed 12768174Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.
- Background: PubMed 37280458Gulak MA, Murphy P. Regurgitation under anesthesia in a fasted patient prescribed semaglutide for weight loss: a case report. Can J Anaesth. 2023 Aug;70(8):1397-1400. doi: 10.1007/s12630-023-02521-3. Epub 2023 Jun 6.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Malikah Latmore, MD principal investigator
Mount Sinai Morningside 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 Gastric Point of Care Ultrasound in people with Obesity and Weight Loss, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Dec 2025. 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?
Contact Diane C Armenta, MD, MS (845-260-0573, Diane.Armenta@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distance from peritoneal wall (time frame: end of the individual's procedure, at 2 hrs after procedure start on postoperative day 0). The study lists 2 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 NCT07310875, which also lists 3 linked publications.
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 30 Dec 2025.