High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Gastroscopy: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Arterial blood gases at end of the procedure
研究概览
简要总结
During gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce modifications to respiratory mechanics, respiratory effort and breathing pattern.
High-flow nasal cannula (HFNC) therapy is a mixed air-oxygen supply system able to deliver heated humidified gas up to 60 L/min of flow rate, with an inspiratory oxygen fraction (FiO2) ranging from 21% to 100%. Increasing evidence supports the use of HFNC in several clinical conditions and settings. When compared to standard therapy (ST), HFNC results in enhanced gas exchange and improved comfort.
No studies have yet assessed the benefits of HFNC versus ST during and after gastroscopy. We designed this unblinded randomized controlled trial to assess whether HFNC, compared to ST, improves oxygenation at the end of the procedure (primary endpoint). Additional endpoints were: 1) the lowest peripheral saturation of oxygen (SpO2) and the number of oxygen desaturations; 2) the changes of end-expiratory lung impedance and tidal impedance assessed by Electrical Impedance Tomography (EIT); 3) the effects on diaphragm function assessed by ultrasound (DUS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatients with the indication to diagnostic gastroscopy
排除标准
- •life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
- •need for invasive or non invasive ventilation
- •presence of pneumothorax or pulmonary enphisema or bullae
- •recent (within 1 week) thoracic surgery
- •presence of chest burns
- •presence of tracheostomy
- •pregnancy
- •nasal or nasopharyngeal diseases
- •lack of consent or its withdrawal
结局指标
主要结局
Arterial blood gases at end of the procedure
时间窗: Through study completion, an average of 15 minutes
Arterial blood will be sample for gas analysis
次要结局
- Respiratory effort at baseline(After 1 minute from study beginning)
- Respiratory effort at end of the procedure(Through study completion, an average of 15 minutes)
- Change of end-expiratory lung impedance (dEELI) from baseline after gastroscopy(After 10 minute from the end of the endoscopy, compared to baseline)
- Respiratory effort after the gastroscopy(After 10 minute from the end of the endoscopy)
- Respiratory effort at the beginning of the gastroscopy(5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment)
- Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the gastroscopy(5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline)
- Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure(Through study completion, an average of 15 minutes)
- Arterial blood gases at baseline(After 1 minute from study beginning)
研究者
Federico Longhini
Director of the Intensive Care and Anesthesia Department
University Magna Graecia