NCT06483984招募中不适用
Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure
Fondazione Policlinico Universitario Agostino Gemelli IRCCS4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Metabolic work of breathing
研究概览
简要总结
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute respiratory failure with
- •PaCO2 ≥ 45 mmHg;
- •Arterial pH < 7.35;
- •Signed written informed consent
排除标准
- •Respiratory rate < 12 bpm;
- •Immediate need for intubation;
- •Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
- •Metabolic Acidosis;
- •Recent head surgery or anatomy that prevent the application of facemasks;
- •Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
- •Any contraindications to facemask noninvasive ventilation.
结局指标
主要结局
Metabolic work of breathing
时间窗: 45 minutes
Simplified pressure-time-product per minute of the transdiaphragmatic pressure
次要结局
- Arterial carbon dioxide, expressed in mmHg(45 minutes)
- Normalized metabolic work of breathing(45 minutes)
- Inspiratory effort, expressed in cmH2O(45 minutes)
- Discomfort(45 minutes)
- End-expiratory lung volume(45 minutes)
- Corrected minute ventilation(45 minutes)
- Dyspnea(45 minutes)
- Regional End-expiratory lung volume(45 minutes)
- Arterial acid-base state(45 minutes)
- Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure(45 minutes)
- Tidal volume distribution(45 minutes)
研究者
研究点 (4)
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