Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- patient's tolerance to the mask
研究概览
简要总结
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device
详细描述
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask.
The subjects will be studied in the sitting position and asked to relax throughout the period of the study.
The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence.
FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study.
End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis
- •sign inform consent
- •able to tolerate the application of NIV
排除标准
- •inability to tolerate the mask
- •contraindication to NIV
- •cancer, neurological diseases, and need of another life support besides the ventilator
研究组 & 干预措施
mask plus CO2 removal device
a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
干预措施: DiMax Zero Total face mask "R", (Device)
traditional face mask
Traditional mask without a CO2 clearance device inserted
干预措施: traditional face mask (Device)
结局指标
主要结局
patient's tolerance to the mask
时间窗: immediate
the tolerance will be recorded using an ad hoc scale
changes in arterial blood gases (ABGs)
时间窗: immediate
Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
次要结局
未报告次要终点
研究者
dr. Stefano Nava
Chief of Pulmonary and Critical Care
IRCCS Azienda Ospedaliero-Universitaria di Bologna