ACTRN12623000926639尚未招募Unknown
The effect of a novel nasal mask on minute ventilation in adults with chronic respiratory failure: A pilot randomised cross-over trial.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •A doctor’s diagnosis of a chronic respiratory and/or cardiovascular disease
- •Oxygen saturation measured by pulse oximetry (SpO2) of less than or equal to 90% while breathing room air
- •PtcCO2 greater than or equal to 45mmHg on transcutaneous monitor at baseline measurement
排除标准
- •Age < 18 years
- •Unable to tolerate oxygen saturations on room air if on long term oxygen therapy
- •Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria
- •Suspected or proven infection with SARS-CoV-2 (COVID-19)
- •Risk of barotrauma, as assessed by the investigator
- •Nasal or facial conditions precluding use of NIV with nasal pillow or oronasal mask
- •Failure of mask fitting test
- •Intracranial trauma or trans-nasal neurosurgery (within 6 weeks)
- •Failure of PulmoVista 500 IET electrode belt fitting (low signal quality, poor skin integrity)
- •Weight <50kg
- •Cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants
- •Self-reported current pregnancy
- •Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
研究者
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