Ultrasound Estimation of Gastric Volumes in Patients With Previous Gastric Sleeve

NCT06533046 | Completed

• 1 other identifier: 24-1278
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aspiration

Keywords

gastric ultrasound; gastric sleeve procedure

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes after ingestion

Secondary Outcomes (2)

• Equation for calculating gastric volume in patients with previous gastric sleeve

  through study completion, an average of one year

• Gastric emptying time

  2 hours after ingestion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have previously undergone gastric sleeve procedure at UNC Hospitals.

You may qualify if:

• Age greater than or equal to 18 years of age
• English speaking
• Previous gastric sleeve procedure

You may not qualify if:

• Gastric surgery in addition to gastric sleeve
• Known hiatal hernia
• Pregnancy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (13)

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  PMID: 19317699 BACKGROUND

• Practice 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.

  PMID: 28045707 BACKGROUND

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  PMID: 23302981 BACKGROUND

• Read 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.

  PMID: 1785235 BACKGROUND

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  PMID: 8431336 BACKGROUND

• Harter 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.

  PMID: 9428870 BACKGROUND

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  PMID: 11682427 BACKGROUND

• Kruisselbrink 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.

  PMID: 29624530 BACKGROUND

• Kruisselbrink 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.

  PMID: 28039244 BACKGROUND

• Howle 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.

  PMID: 32693329 BACKGROUND

• 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.

  PMID: 29985844 BACKGROUND

• Clapp 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.

  PMID: 38448343 BACKGROUND

Study Officials

• Alexander Doyal, MD, MPH, FASA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 1, 2024
• Study Start: August 2, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: February 25, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 9 to 36 months following publication and will be available indefinitely.
• Access Criteria: The investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Locations

US (1)