AspirationNCT06533046
Ultrasound Estimation of Gastric Volumes in Patients With Previous Gastric Sleeve
An observational study of Aspiration, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this observational study is to determine whether the existing model for calculating gastric volume based on an ultrasound-measured cross sectional area is accurate in adults who have had a previous gastric sleeve procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aspiration
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 15 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have previously undergone gastric sleeve procedure at UNC Hospitals.
Who may be able to join
- Age greater than or equal to 18 years of age
- English speaking
- Previous gastric sleeve procedure
Who cannot join
- Gastric surgery in addition to gastric sleeve
- Known hiatal hernia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
The goal of this observational study is to determine whether the existing model for calculating gastric volume based on an ultrasound-measured cross sectional area is accurate in adults who have had a previous gastric sleeve procedure. The main questions it aims to answer are:
Can the existing model accurately calculate gastric volume in patients who have had a previous gastric sleeve procedure?
Read more
If the existing model is not accurate in this population, can a model be developed to predict gastric volume in these patients based on ultrasound-measured cross section area?
Participants will be asked to fast prior to presenting for a gastric ultrasound scan. Following a fasted scan, patients will drink a small volume of water and undergo a second gastric scan.
Read the detailed description
A major complication related to anesthesia in the perioperative period is aspiration of gastric contents. Multiple population level studies have found that aspiration among the leading causes of death from airway complications associated with anesthesia. In order to minimize the risk of aspiration, patients are often fasted prior to surgery if possible with the goal of emptying the stomach. Guidelines from the American Society of Anesthesiologists suggest that the existing evidence supports a 2 hour fast from clear fluids, a minimum of 6 hours from light foods such as toast, and even greater fasting times such as 8 hours or more from heavier foods such as meat. However, there is often a lack of clarity as to whether patients are adequately fasted prior to surgery especially elective surgery patients coming from home. This presents a dilemma of whether additional precautions need to be taken during surgery or even if the case needs to be cancelled.
One tool that has been used by anesthesiologists to clarify the risk of a full stomach preoperatively is an estimation of gastric volume using bedside ultrasound. The most commonly utilized method of estimating gastric volume is done by laying the patient in the right lateral decubitus position, measuring the diameter of stomach at the level of the antrum, and estimating a volume using the formula stomach volume (mL) = 27 + 14.6* antral cross sectional area (cm2) - 1.28*age (years). Volumes up to 1.5 mL/kg are generally thought to be consistent with baseline gastric secretions, while higher volumes or the presence of solids on ultrasound are indicative of a relatively full stomach and elevated aspiration risk. Gastric ultrasound and this method of estimating volume have been found to be very sensitive and specific for identifying a full stomach including in pregnant and severely obese patients.
Despite the proven accuracy of bedside ultrasound in estimating gastric volume in a variety of populations, all studies in the literature excluded patients who had previous gastric surgeries. There is a single published case study of an attempt to obtain an ultrasound estimate of gastric volume in a patient who had a previous roux-en-Y gastric bypass. This report found that the patient's stomach appeared to be empty on ultrasound regardless of ingested volume because the antrum of the stomach is no longer continuous with the remainder of the gastrointestinal tract after the operation. This is not the case in gastric sleeve procedures in which the greater curvature of the stomach is resected but the flow of material in the tract is left intact. Notably, an estimated 280,000 bariatric procedures were performed in the United States in 2022 with the vast majority of these being gastric sleeves. Given the large and ever increasing population of patients who have had gastric sleeve procedures and the proven utility of gastric ultrasound in assessing appropriate preoperative fasting it is important to determine whether traditional models of estimating gastric volume retain their accuracy in this population.
Participants will be asked to fast from solids for 8 hours and fluids for 2 hours prior to presenting for the study to ensure an empty stomach at baseline. They will be asked to lay on a flat surface on their right side. A curvilinear ultrasound probe will be placed on their abdomen and the antrum of the stomach will be identified with the liver and aorta in view at which point 3 measurements of both the anteroposterior and craniocaudal diameter of the stomach will be taken. These measurements will be used to calculate a gastric volume. Participants will then be asked to drink 100 mL of water. A second set of measurements of the gastric antrum will be obtained within 5 minutes of ingestion of the water as previously described. Serial measurements will be taken at thirty-minute intervals until 2 hours have past since ingestion. Participants will then be asked if they would be willing to repeat the above process at a later date. If they agree to go forward with an additional date, they will be asked to undergo the same process detailed above but with ingestion of 200 mL of water. If they are amenable to presenting a third time they will undergo a final trial with 300 mL of water as described above.
- Conditions
- Aspiration
- Keywords
- gastric ultrasound, gastric sleeve procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of existing gastric volume equation
Calculated gastric volumes from after participants ingestion of a known quantity of water during the study will be compared to the known volumes of water that the subjects ingested using a mean squared error analysis.
Measured: 5 minutes after ingestion
Secondary outcomes (2)
Equation for calculating gastric volume in patients with previous gastric sleeve
Should the existing model prove to be inaccurate, LASSO regression will be performed to identify a more accurate model in this population based on comparing the known volumes of water ingested and the measured cross sectional gastric area.
Measured: through study completion, an average of one year
Gastric emptying time
The thirty-minute interval scans following ingestion will be used to determine the approximate time at which each patient is able to fully empty the volume of water they have ingested.
Measured: 2 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start2 Aug 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AspirationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Doyal, MD, MPH, FASA, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533046
- Sponsor's protocol ID
- 24-1278
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
PubMed 21447488Auroy Y, Benhamou D, Pequignot F, Bovet M, Jougla E, Lienhart A. Mortality related to anaesthesia in France: analysis of deaths related to airway complications. Anaesthesia. 2009 Apr;64(4):366-70. doi: 10.1111/j.1365-2044.2008.05792.x.
PubMed 19317699Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
PubMed 23302981Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.
PubMed 1785235Phillips S, Hutchinson S, Davidson T. Preoperative drinking does not affect gastric contents. Br J Anaesth. 1993 Jan;70(1):6-9. doi: 10.1093/bja/70.1.6.
PubMed 8431336Harter RL, Kelly WB, Kramer MG, Perez CE, Dzwonczyk RR. A comparison of the volume and pH of gastric contents of obese and lean surgical patients. Anesth Analg. 1998 Jan;86(1):147-52. doi: 10.1097/00000539-199801000-00030.
PubMed 9428870Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
PubMed 11682427Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PubMed 29624530Kruisselbrink R, Arzola C, Jackson T, Okrainec A, Chan V, Perlas A. Ultrasound assessment of gastric volume in severely obese individuals: a validation study. Br J Anaesth. 2017 Jan;118(1):77-82. doi: 10.1093/bja/aew400.
PubMed 28039244Howle R, Sultan P, Shah R, Sceales P, Van de Putte P, Bampoe S. Gastric point-of-care ultrasound (PoCUS) during pregnancy and the postpartum period: a systematic review. Int J Obstet Anesth. 2020 Nov;44:24-32. doi: 10.1016/j.ijoa.2020.05.005. Epub 2020 May 29.
PubMed 32693329Pai 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 29985844Clapp B, Ponce J, Corbett J, Ghanem OM, Kurian M, Rogers AM, Peterson RM, LaMasters T, English WJ. American Society for Metabolic and Bariatric Surgery 2022 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2024 May;20(5):425-431. doi: 10.1016/j.soard.2024.01.012. Epub 2024 Feb 1.
PubMed 38448343
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Estimation of Gastric Volumes in Patients With Previous Gastric Sleeve
- ClinicalTrials.gov ID
- NCT06533046
- Acronym / sponsor ID
- 24-1278
- Conditions
- Aspiration
- Keywords
- gastric ultrasound, gastric sleeve procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 1 Aug 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.
The goal of this observational study is to determine whether the existing model for calculating gastric volume based on an ultrasound-measured cross sectional area is accurate in adults who have had a previous gastric sleeve procedure. The main questions it aims to answer are:
Can the existing model accurately calculate gastric volume in patients who have had a previous gastric sleeve procedure?
If the existing model is not accurate in this population, can a model be developed to predict gastric volume in these patients based on ultrasound-measured cross section area?
Participants will be asked to fast prior to presenting for a gastric ultrasound scan. Following a fasted scan, patients will drink a small volume of water and undergo a second gastric scan.
Detailed description
A major complication related to anesthesia in the perioperative period is aspiration of gastric contents. Multiple population level studies have found that aspiration among the leading causes of death from airway complications associated with anesthesia. In order to minimize the risk of aspiration, patients are often fasted prior to surgery if possible with the goal of emptying the stomach. Guidelines from the American Society of Anesthesiologists suggest that the existing evidence supports a 2 hour fast from clear fluids, a minimum of 6 hours from light foods such as toast, and even greater fasting times such as 8 hours or more from heavier foods such as meat. However, there is often a lack of clarity as to whether patients are adequately fasted prior to surgery especially elective surgery patients coming from home. This presents a dilemma of whether additional precautions need to be taken during surgery or even if the case needs to be cancelled.
One tool that has been used by anesthesiologists to clarify the risk of a full stomach preoperatively is an estimation of gastric volume using bedside ultrasound. The most commonly utilized method of estimating gastric volume is done by laying the patient in the right lateral decubitus position, measuring the diameter of stomach at the level of the antrum, and estimating a volume using the formula stomach volume (mL) = 27 + 14.6* antral cross sectional area (cm2) - 1.28*age (years). Volumes up to 1.5 mL/kg are generally thought to be consistent with baseline gastric secretions, while higher volumes or the presence of solids on ultrasound are indicative of a relatively full stomach and elevated aspiration risk. Gastric ultrasound and this method of estimating volume have been found to be very sensitive and specific for identifying a full stomach including in pregnant and severely obese patients.
Despite the proven accuracy of bedside ultrasound in estimating gastric volume in a variety of populations, all studies in the literature excluded patients who had previous gastric surgeries. There is a single published case study of an attempt to obtain an ultrasound estimate of gastric volume in a patient who had a previous roux-en-Y gastric bypass. This report found that the patient's stomach appeared to be empty on ultrasound regardless of ingested volume because the antrum of the stomach is no longer continuous with the remainder of the gastrointestinal tract after the operation. This is not the case in gastric sleeve procedures in which the greater curvature of the stomach is resected but the flow of material in the tract is left intact. Notably, an estimated 280,000 bariatric procedures were performed in the United States in 2022 with the vast majority of these being gastric sleeves. Given the large and ever increasing population of patients who have had gastric sleeve procedures and the proven utility of gastric ultrasound in assessing appropriate preoperative fasting it is important to determine whether traditional models of estimating gastric volume retain their accuracy in this population.
Participants will be asked to fast from solids for 8 hours and fluids for 2 hours prior to presenting for the study to ensure an empty stomach at baseline. They will be asked to lay on a flat surface on their right side. A curvilinear ultrasound probe will be placed on their abdomen and the antrum of the stomach will be identified with the liver and aorta in view at which point 3 measurements of both the anteroposterior and craniocaudal diameter of the stomach will be taken. These measurements will be used to calculate a gastric volume. Participants will then be asked to drink 100 mL of water. A second set of measurements of the gastric antrum will be obtained within 5 minutes of ingestion of the water as previously described. Serial measurements will be taken at thirty-minute intervals until 2 hours have past since ingestion. Participants will then be asked if they would be willing to repeat the above process at a later date. If they agree to go forward with an additional date, they will be asked to undergo the same process detailed above but with ingestion of 200 mL of water. If they are amenable to presenting a third time they will undergo a final trial with 300 mL of water as described above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have previously undergone gastric sleeve procedure at UNC Hospitals.
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years of age
- English speaking
- Previous gastric sleeve procedure
Key exclusion criteria (3 listed)
- Gastric surgery in addition to gastric sleeve
- Known hiatal hernia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of existing gastric volume equation
Time frame: 5 minutes after ingestion
Calculated gastric volumes from after participants ingestion of a known quantity of water during the study will be compared to the known volumes of water that the subjects ingested using a mean squared error analysis.
2 secondary outcomes
Equation for calculating gastric volume in patients with previous gastric sleeve
Time frame: through study completion, an average of one year
Gastric emptying time
Time frame: 2 hours after ingestion
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 25 Feb 2025.
- Background: PubMed 21447488Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Background: PubMed 19317699Auroy Y, Benhamou D, Pequignot F, Bovet M, Jougla E, Lienhart A. Mortality related to anaesthesia in France: analysis of deaths related to airway complications. Anaesthesia. 2009 Apr;64(4):366-70. doi: 10.1111/j.1365-2044.2008.05792.x.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 23302981Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
- Background: PubMed 1785235Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.
- Background: PubMed 8431336Phillips S, Hutchinson S, Davidson T. Preoperative drinking does not affect gastric contents. Br J Anaesth. 1993 Jan;70(1):6-9. doi: 10.1093/bja/70.1.6.
- Background: PubMed 9428870Harter RL, Kelly WB, Kramer MG, Perez CE, Dzwonczyk RR. A comparison of the volume and pH of gastric contents of obese and lean surgical patients. Anesth Analg. 1998 Jan;86(1):147-52. doi: 10.1097/00000539-199801000-00030.
- Background: PubMed 11682427Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
- Background: PubMed 29624530Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
- Background: PubMed 28039244Kruisselbrink R, Arzola C, Jackson T, Okrainec A, Chan V, Perlas A. Ultrasound assessment of gastric volume in severely obese individuals: a validation study. Br J Anaesth. 2017 Jan;118(1):77-82. doi: 10.1093/bja/aew400.
- Background: PubMed 32693329Howle R, Sultan P, Shah R, Sceales P, Van de Putte P, Bampoe S. Gastric point-of-care ultrasound (PoCUS) during pregnancy and the postpartum period: a systematic review. Int J Obstet Anesth. 2020 Nov;44:24-32. doi: 10.1016/j.ijoa.2020.05.005. Epub 2020 May 29.
- 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Alexander Doyal, MD, MPH, FASA principal investigator
University of North Carolina, Chapel Hill
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 Aspiration, run by University of North Carolina, Chapel Hill 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 3 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 25 Feb 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?
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?
Accuracy of existing gastric volume equation (time frame: 5 minutes after ingestion). 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 NCT06533046, which also lists 13 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 25 Feb 2025.