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

Официальное название

ULTRASOUND ASSESSMENT of GASTRIC CONTENT in FASTED PREGNANT WOMEN: PROSPECTIVE OBSERVATIONAL STUDY

Обзор

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).

Подробное описание

The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted high-risk pregnant women in the 3rd trimester.

The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.

Вмешательства

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

Первичные конечные точки

• Qualitative assessment of the antrum of the stomach [Срок оценки: 10 min]

Вторичные конечные точки (1)

• Quantitative assessment of the antrum of the stomach [Срок оценки: 10 min]

Критерии участия

Критерии включения

• Non-labouring pregnant women at 3rd trimester (≥ 28 weeks)
• 18 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06803225 · 1346-24-SMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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