High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy

Официальное название

High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.

Обзор

During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia. Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.

Вмешательства

• Процедура High Flow Nasal Cannula Oxygenation
  High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
• Процедура Face Mask Oxygenation
  conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute

Первичные конечные точки

• Incidence of hypoxia [Срок оценки: From sedation with propofol to the end of the gastroscopy]

Вторичные конечные точки (4)

• Incidence of subclinical respiratory depression [Срок оценки: From sedation with propofol to the end of the gastroscopy]
• Severe hypoxia [Срок оценки: From sedation with propofol to the end of the gastroscopy]
• Serious cardiac events [Срок оценки: Through gastroscopy completion, an average of 10-15 minutes]
• Serious adverse respiratory events [Срок оценки: Through gastroscopy completion, an average of 10-15 minutes]

Критерии участия

Критерии включения

• ASA class ≤Ⅲ
• Visceral obesity（body mass index≥28 and BRI ≥5.46）
• Patients who will undergo sedated gastroscopy

Критерии исключения

• Life-threatening heart disease or acute myocardial infarction within 6 weeks
• Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema
• Upper respiratory tract infection
• Presence of tracheostomy
• Nasal or nasopharyngeal diseases
• Coagulation disorders or a tendency of nose bleeding
• Pregnancy
• Recent (within 1 week) thoracic surgery
• Emergent procedure or surgery
• Allergy to drugs used during the procedure
• Unwillingness to participate in the study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Zhongshan Hospitla — Шанхай

Идентификаторы

NCT: NCT07159022 · B2025-212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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