Gastric Content AspirationNCT05875636
GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy
An observational study of Gastric Content Aspiration, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Content Aspiration
- What is being tested?
- Esophagogastroduodenoscopy
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 23 Aug 2024
- 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: This study will consist of patients who have appropriately fasted, and are scheduled for an esophagogastroduodenoscopy (EGD). Patients will fall in to two groups: 1) taking a GLP-1 receptor agonist or 2) not taking a receptor agonist medication.
Who may be able to join
- Adults 18 years of age and older presenting for esophagogastroduodenoscopy (EGD)
- One of the following groups:
- GLP-1 receptor agonist cohort: active treatment with any GLP-1 receptor agonist therapy within prior 30 days
- Control cohort: not taking a GLP-1 receptor agonist medication
- Appropriately fasted per ASA Fasting Guidelines
Who cannot join
- Simultaneous bowel preparation/planned dual endoscopy with colonoscopy
- Any pre-planned alteration to standard fasting guidelines (ASA NPO guidelines)
- Emergency endoscopic procedure
- Concern for active GI bleeding
- Food impaction/foreign body as indication for procedure
- Gastric outlet obstruction/bowel obstruction
Show all 13Show fewer
- Achalasia
- Zenker's diverticulum
- History of esophageal or gastric surgery
- Active pregnancy
- Chronic daily opioid therapy ≥ 15 MMEs per day
- Prokinetic agent use (i.e. metoclopramide)
- Inability or unwillingness of subject to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29424
About this study
This study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Study data will be collected in the form of qualitatively observing whether the stomach is empty as expected, or contains solid or clinically relevant liquid contents.
- Conditions
- Gastric Content Aspiration
- Being tested
- Esophagogastroduodenoscopy
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyOther
All patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Patients taking a GLP-1 agonist medication | Participants meeting all inclusion/exclusion criteria who are taking a GLP-1 agonist medication Receives: Other: Esophagogastroduodenoscopy | |
| Controls | Participants meeting all inclusion/exclusion criteria and are NOT taking a GLP-1 agonist medication. Receives: Other: Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retained gastric food
Incidence of clinically significant retained gastric food, defined as visible solid/particulate matter, or liquid volume > 1.5cc/kg
Measured: From time of enrollment until the end of surgery, assessed up to 4 weeks
Secondary outcomes (1)
Incidence of pulmonary aspiration event
Measured: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start21 Aug 2023
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Content AspirationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Wilson, Medical University of South Carolina
- Investigators
- Phillip R Wilson, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875636
- Sponsor's protocol ID
- Pro00129059
- Status last verified
- Sep 2024
- First submitted
- 16 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy
- ClinicalTrials.gov ID
- NCT05875636
- Acronym / sponsor ID
- Pro00129059
- Conditions
- Gastric Content Aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 25 May 2023 (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 study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Study data will be collected in the form of qualitatively observing whether the stomach is empty as expected, or contains solid or clinically relevant liquid contents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients taking a GLP-1 agonist medication | – | Other: EsophagogastroduodenoscopyParticipants meeting all inclusion/exclusion criteria who are taking a GLP-1 agonist medication |
| Controls | – | Other: EsophagogastroduodenoscopyParticipants meeting all inclusion/exclusion criteria and are NOT taking a GLP-1 agonist medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of patients who have appropriately fasted, and are scheduled for an esophagogastroduodenoscopy (EGD). Patients will fall in to two groups: 1) taking a GLP-1 receptor agonist or 2) not taking a receptor agonist medication.
Key inclusion criteria (5 listed)
- Adults 18 years of age and older presenting for esophagogastroduodenoscopy (EGD)
- One of the following groups:
- Appropriately fasted per ASA Fasting Guidelines
Key exclusion criteria (13 listed)
- Simultaneous bowel preparation/planned dual endoscopy with colonoscopy
- Any pre-planned alteration to standard fasting guidelines (ASA NPO guidelines)
- Emergency endoscopic procedure
- Concern for active GI bleeding
- Food impaction/foreign body as indication for procedure
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 |
|---|---|---|
| EsophagogastroduodenoscopyAll patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled. | Other | Controls, Patients taking a GLP-1 agonist medication |
Primary outcome
Retained gastric food
Time frame: From time of enrollment until the end of surgery, assessed up to 4 weeks
Incidence of clinically significant retained gastric food, defined as visible solid/particulate matter, or liquid volume > 1.5cc/kg
1 secondary outcome
Incidence of pulmonary aspiration event
Time frame: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
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 19 Sep 2024.
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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.
Phillip R Wilson, M.D. principal investigator
Medical University of South Carolina
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 Gastric Content Aspiration, run by Medical University of South Carolina 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 5 inclusion and 13 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 19 Sep 2024. 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?
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?
Retained gastric food (time frame: From time of enrollment until the end of surgery, assessed up to 4 weeks). 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 19 Sep 2024.