Ultrasound Assessment of Gastric Volume in High-Risk Pregnant Women At Term

NCT06803225 | Not Yet Recruiting

• 1 other identifier: 1346-24-SMC
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The risk of pulmonary aspiration of gastric contents remains a significant risk during anesthesia, especially in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This prospective observational study aimed to (1) qualitatively and quantitatively describe the sonographic appearance of the gastric antrum in fasted high-risk pregnant women during the third trimester and (2) evaluate the relationship between demographic and clinical variables and the gastric antral cross-sectional area (CSA).

Conditions

Pregnancy; Respiratory Aspiration of Gastric Content

Outcome Measures

Primary Outcomes (1)

• Qualitative assessment of the antrum of the stomach

  Patients will be classified as follows; Grade 0: the antrum appears empty on both supine and right lateral decubitus positions; grade 1: gastric fluid is visible on the right lateral decubitus position only, suggesting a small fluid volume; and grade 2: gastric fluid is observed in the antrum in both supine and right lateral decubitus, suggesting a larger fluid volume.

  10 min

Secondary Outcomes (1)

• Quantitative assessment of the antrum of the stomach

  10 min

Interventions

Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer DIAGNOSTIC_TEST

Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fasted (6h solids, 2h fluids) high-risk pregnant women at 3rd trimester

You may qualify if:

• Non-labouring pregnant women at 3rd trimester (≥ 28 weeks)
• years or older.
• ASA physical status I-III
• Hospitilized in High Risk Pregnancy Department
• Ability to understand the rationale of the study assessments and provide signed informed consent.
• Written informed consent

You may not qualify if:

• Patients with American Society of Anesthesiology (ASA) physical status class IV.
• Patient age \< 18 years
• Pregnant patients with upper gastrointestinal (GI) disease and pathology.
• History of upper GI tract surgical procedures.
• History of medications that affect gastrointestinal motility.
• Inability to understand the rationale of the study assessments and provide signed informed consent.

Sponsors & Collaborators

• The Chaim Sheba Medical Center: lead

Related Publications (10)

• Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.

  PMID: 26580836 BACKGROUND

• Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.

  PMID: 29230709 BACKGROUND

• Roukhomovsky M, Zieleskiewicz L, Diaz A, Guibaud L, Chaumoitre K, Desgranges FP, Leone M, Chassard D, Bouvet L; AzuRea, CAR'Echo Collaborative Networks. Ultrasound examination of the antrum to predict gastric content volume in the third trimester of pregnancy as assessed by MRI: A prospective cohort study. Eur J Anaesthesiol. 2018 May;35(5):379-389. doi: 10.1097/EJA.0000000000000749.

  PMID: 29210844 BACKGROUND

• Zieleskiewicz L, Bouvet L, Einav S, Duclos G, Leone M. Diagnostic point-of-care ultrasound: applications in obstetric anaesthetic management. Anaesthesia. 2018 Oct;73(10):1265-1279. doi: 10.1111/anae.14354. Epub 2018 Jul 26.

  PMID: 30047997 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

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 BACKGROUND

• Dean G, Jacobs AR, Goldstein RC, Gevirtz CM, Paul ME. The safety of deep sedation without intubation for abortion in the outpatient setting. J Clin Anesth. 2011 Sep;23(6):437-42. doi: 10.1016/j.jclinane.2011.05.001. Epub 2011 Aug 9.

  PMID: 21831622 BACKGROUND

• D'Angelo R, Smiley RM, Riley ET, Segal S. Serious complications related to obstetric anesthesia: the serious complication repository project of the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2014 Jun;120(6):1505-12. doi: 10.1097/ALN.0000000000000253.

  PMID: 24845921 BACKGROUND

• Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.

  PMID: 16563326 BACKGROUND

• MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.

  PMID: 20993766 BACKGROUND

Central Study Contacts

Maxim Glebov Dr Maxim Glebov, MD

CONTACT

+972585893324; hlebau@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share