Respiratory Aspiration of Gastric ContentsNCT03310528
Gastric Ultrasound for Estimation of the Aspiration Risk Study
An observational study of Respiratory Aspiration of Gastric Contents, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to look at the effectiveness of current anesthesia guidelines regarding food and drink prior to surgery in patients who are likely to have food and drink remain in their stomach longer than might ordinarily be expected. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Aspiration of Gastric Contents
- What is being tested?
- Interview questionnaire and Gastric ultrasound exam
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 14 Jul 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for upper GI endoscopy and/or endoscopic retrograde cholangiopancreatogram (ERCP), expected to have an oral-gastric tube placed as part of scheduled procedure.
Who may be able to join
- Presenting for upper GI endoscopy procedures or surgical repair of a trauma- related injury
- Expected to have an oral-gastric tube placed as part of scheduled procedure
- Willing to undergo an ultrasound exam
- Patients ≥ 18 years of age
Who cannot join
- Unwilling to undergo an ultrasound exam
- Oral-gastric tube placement is not indicated
- Oral-gastric tube placement is contraindicated
- Pregnant patients and patients from defined vulnerable populations (ex. pediatric patients, mentally handicapped patients, prisoners, etc.)
- Surgical trauma patients who are not expected to have an OG tube placed during surgery
- Patients with history of gastric bypass surgery
- Patients that are gastrostomy tube dependent
Trial locations and contacts
1 site in 1 country.
United States1 site
United States, Florida UF Health
Gainesville, Florida, 32610-3003
About this study
Official title: Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations
The purpose of this research study is to look at the effectiveness of current anesthesia guidelines regarding food and drink prior to surgery in patients who are likely to have food and drink remain in their stomach longer than might ordinarily be expected.
Read the detailed description
Examine the utility of ultrasound examination of the stomach in estimating aspiration risk in patient populations whose aspiration risk is currently poorly understood. Evaluate the applicability of current pre-surgical fasting guidelines in the same patient populations whose aspiration risk is poorly understood.
Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have adhered to pre-operative fasting guidelines. Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have not adhered to pre-operative fasting guidelines. Only patients expected to have an oral-gastric tube placed during upper GI endoscopy procedure will be included. Both groups will be evaluated to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.
- Being tested
- Interview questionnaire, Gastric ultrasound exam
- Keywords
- Aspiration risk, GI Endoscopy, Fasting guidelines, Delayed gastric emptying
- Medical subject headings
- Respiratory Aspiration of Gastric Contents, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview questionnaireBehavioural
Complete interview questionnaire regarding the composition and timing of their most recent food intake.
Gastric ultrasound examProcedure or surgery
Gastric ultrasound exam prior to upper GI endoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Obeyed fasting guidelines | Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. Receives: Behavioral: Interview questionnaire; Procedure: Gastric ultrasound exam | |
| Did not obey fasting guidelines | Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. Receives: Behavioral: Interview questionnaire; Procedure: Gastric ultrasound exam | |
| Trauma - obeyed fasting guidelines | Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. Receives: Behavioral: Interview questionnaire; Procedure: Gastric ultrasound exam | |
| Trauma - did not obey fasting guidelines | Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. Receives: Behavioral: Interview questionnaire; Procedure: Gastric ultrasound exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gastric content volume between the four groups assessed by ultrasound examination
Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start27 Mar 2018
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Aspiration of Gastric ContentsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron Smith, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310528
- Sponsor's protocol ID
- IRB201602234
- Other IDs
- OCR18887
- Status last verified
- Jul 2025
- First submitted
- 4 Oct 2017
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations
- ClinicalTrials.gov ID
- NCT03310528
- Acronym / sponsor ID
- IRB201602234
- Keywords
- Aspiration risk, GI Endoscopy, Fasting guidelines, Delayed gastric emptying
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 16 Oct 2017 (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.
The purpose of this research study is to look at the effectiveness of current anesthesia guidelines regarding food and drink prior to surgery in patients who are likely to have food and drink remain in their stomach longer than might ordinarily be expected.
Detailed description
Examine the utility of ultrasound examination of the stomach in estimating aspiration risk in patient populations whose aspiration risk is currently poorly understood. Evaluate the applicability of current pre-surgical fasting guidelines in the same patient populations whose aspiration risk is poorly understood.
Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have adhered to pre-operative fasting guidelines. Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have not adhered to pre-operative fasting guidelines. Only patients expected to have an oral-gastric tube placed during upper GI endoscopy procedure will be included. Both groups will be evaluated to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obeyed fasting guidelines | – | Behavioral: Interview questionnaire, Procedure: Gastric ultrasound examScheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. |
| Did not obey fasting guidelines | – | Behavioral: Interview questionnaire, Procedure: Gastric ultrasound examScheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. |
| Trauma - obeyed fasting guidelines | – | Behavioral: Interview questionnaire, Procedure: Gastric ultrasound examScheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. |
| Trauma - did not obey fasting guidelines | – | Behavioral: Interview questionnaire, Procedure: Gastric ultrasound examScheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for upper GI endoscopy and/or endoscopic retrograde cholangiopancreatogram (ERCP), expected to have an oral-gastric tube placed as part of scheduled procedure.
Key inclusion criteria (4 listed)
- Presenting for upper GI endoscopy procedures or surgical repair of a trauma- related injury
- Expected to have an oral-gastric tube placed as part of scheduled procedure
- Willing to undergo an ultrasound exam
- Patients ≥ 18 years of age
Key exclusion criteria (7 listed)
- Unwilling to undergo an ultrasound exam
- Oral-gastric tube placement is not indicated
- Oral-gastric tube placement is contraindicated
- Pregnant patients and patients from defined vulnerable populations (ex. pediatric patients, mentally handicapped patients, prisoners, etc.)
- Surgical trauma patients who are not expected to have an OG tube placed during 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 |
|---|---|---|
| Interview questionnaireComplete interview questionnaire regarding the composition and timing of their most recent food intake. | Behavioural | Did not obey fasting guidelines, Obeyed fasting guidelines, Trauma - did not obey fasting guidelines, Trauma - obeyed fasting guidelines |
| Gastric ultrasound examGastric ultrasound exam prior to upper GI endoscopy procedure. | Procedure or surgery | Did not obey fasting guidelines, Obeyed fasting guidelines, Trauma - did not obey fasting guidelines, Trauma - obeyed fasting guidelines |
Primary outcome
Changes in gastric content volume between the four groups assessed by ultrasound examination
Time frame: Up to 12 hours
Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.
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 22 Sep 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.
Cameron Smith, MD, PhD principal investigator
University of Florida
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 Respiratory Aspiration of Gastric Contents, run by University of Florida 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 4 inclusion and 7 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 22 Sep 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 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?
Changes in gastric content volume between the four groups assessed by ultrasound examination (time frame: Up to 12 hours). 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 22 Sep 2026.