Short Term Physiological Effects of Nasal High Oxygen Flow vs Low Oxygen Flow and Noninvasive Ventilation (NIV) on Respiratory Mechanics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- recording of respiratory mechanics
研究概览
简要总结
Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in hypoxic patients and ameliorate breathing pattern in hypercapnic patients.
The aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.
详细描述
Subjects. 10 in-patients with stable COPD and chronic hypercapnic respiratory failure with no history of neurological or chronic cardiac disease will be recruited. They need to be in a phase of clinical stability and were for a short period of rehabilitation. Patients with X-ray evidence of pulmonary edema or congestion and pulmonary infiltrate will be excluded from the study. Written consent will be obtained from all subjects, and the protocol will be approved by the Ethics Committee.
Measurements. Static and dynamic lung volumes assessed by body plethysmography (MasterLab-Jaeger, Hochberg, Germany).
Flow measured with a pneumotachograph (Screenmate Box 0586, Jaeger GmbH, Hochberg, Germany), connected to a rigid mouthpiece.
Airway pressure measured through tubing inserted in the mouthpiece and connected to a differential pressure transducer (Honeywell 300 cm H2O, Freeport, IL, USA). VT obtained by integration of the flow signal. The inspiratory (TI), expiratory (TE) and total breathing cycle (TTOT) duration, respiratory frequency (RR), and duty cycle (TI/TTOT) calculated as average values of 10 consecutive breaths, after 5 minutes of breathing.
Baseline from peak changes in esophageal (Pes), gastric (Pga), and transdiaphragmatic (Pdi) pressures measured using the balloon-catheter technique. Pressure at the airway opening (Paw) measured via a side port.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients
- •Chronic hypercapnic respiratory failure (pH>7.34 and PaCO2>45 mmHg)
排除标准
- •Neurological and cardiac disease
研究组 & 干预措施
HOF30
the patients will be asked to breathe with HOF of 30 L/min
干预措施: noninvasive mechanical ventilation (NIV) (Device)
spontaneous breathing trial
the patients will be asked to breathe spontaneously using their acutal low oxygen flow
干预措施: HOF (Device)
spontaneous breathing trial
the patients will be asked to breathe spontaneously using their acutal low oxygen flow
干预措施: noninvasive mechanical ventilation (NIV) (Device)
HOF20
the patients will be asked to breathe with HOF of 20 L/min
干预措施: HOF (Device)
HOF20
the patients will be asked to breathe with HOF of 20 L/min
干预措施: noninvasive mechanical ventilation (NIV) (Device)
HOF30
the patients will be asked to breathe with HOF of 30 L/min
干预措施: HOF (Device)
noninvasive mechanical ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
干预措施: HOF (Device)
noninvasive mechanical ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
干预措施: noninvasive mechanical ventilation (NIV) (Device)
结局指标
主要结局
recording of respiratory mechanics
时间窗: 30 minutes per arm
Respiratory mechanics will be assessed using Mead and Wittenberger's technique.
次要结局
- dyspnea score(30 minutes per arm)
研究者
dr. Stefano Nava
Chief of Respiratory and Critical care Unit
IRCCS Azienda Ospedaliero-Universitaria di Bologna