Pulmonary AspirationNCT06263595
Semaglutide and Preoperative Residual Gastric Volumes
An observational study of Pulmonary Aspiration, run by University of Calgary at 1 site in Canada.
Trial summary
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Aspiration
- What is being tested?
- gastric antral sonography
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2024to 16 May 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective surgical patients meeting inclusion/exclusion criteria at the South Health Campus (Calgary, AB, Canada)
Who may be able to join
- all elective surgical patients (> 18 years of age)
- followed institutional fasting protocol for surgery
- patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
- patients not taking GLP-1 receptor agonist (N =45)
Who cannot join
- confounding delayed gastric emptying due to pregnancy
- previous esophageal or gastric operation
- etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
- on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.
To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.
Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.
- Conditions
- Pulmonary Aspiration
- Being tested
- gastric antral sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric antral sonographyDevice
Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 Agonist Group | Intervention: elective surgical patients taking GLP-1 receptor agonists Receives: Device: gastric antral sonography | |
| Non GLP-1 Agonist Group | Intervention: elective surgical patients not taking GLP-1 receptor agonists Receives: Device: gastric antral sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants presenting with a full stomach
Full stomach defined as either clear fluid > 1.5ml/kg or solid content found with point-of-care gastric antral sonography.
Measured: Measured in the preoperative holding area
Secondary outcomes (3)
Number of occurrences requiring change in anesthetic management plan
Changes in plan include those from laryngeal mask airway to more advanced endotracheal tube with rapid sequence induction and intubation or spinal anesthetic without sedation to administration of a general anesthetic.
Measured: From time of preoperative ultrasound in holding area to anesthesia induction in operating room
Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume
Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume
Measured: Measured in the preoperative holding area
Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration
Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management
Measured: Measured in the preoperative holding area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start31 May 2024
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AspirationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Joanna Moser, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263595
- Sponsor's protocol ID
- REB23-1754
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
- ClinicalTrials.gov ID
- NCT06263595
- Acronym / sponsor ID
- REB23-1754
- Conditions
- Pulmonary Aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 31 May 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 16 Feb 2024 (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.
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.
To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.
Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 Agonist Group | – | Device: gastric antral sonographyIntervention: elective surgical patients taking GLP-1 receptor agonists |
| Non GLP-1 Agonist Group | – | Device: gastric antral sonographyIntervention: elective surgical patients not taking GLP-1 receptor agonists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgical patients meeting inclusion/exclusion criteria at the South Health Campus (Calgary, AB, Canada)
Key inclusion criteria (4 listed)
- all elective surgical patients (> 18 years of age)
- followed institutional fasting protocol for surgery
- patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
- patients not taking GLP-1 receptor agonist (N =45)
Key exclusion criteria (4 listed)
- confounding delayed gastric emptying due to pregnancy
- previous esophageal or gastric operation
- etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
- on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
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 antral sonographyParticipant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed. | Device | GLP-1 Agonist Group, Non GLP-1 Agonist Group |
Primary outcome
Number of participants presenting with a full stomach
Time frame: Measured in the preoperative holding area
Full stomach defined as either clear fluid > 1.5ml/kg or solid content found with point-of-care gastric antral sonography.
3 secondary outcomes
Number of occurrences requiring change in anesthetic management plan
Time frame: From time of preoperative ultrasound in holding area to anesthesia induction in operating room
Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume
Time frame: Measured in the preoperative holding area
Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration
Time frame: Measured in the preoperative holding area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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.
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?
An observational study of Pulmonary Aspiration, run by University of Calgary at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 28 Apr 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants presenting with a full stomach (time frame: Measured in the preoperative holding area). 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 28 Apr 2026.