Safety and Usability of the LUMENA Non-invasive Ventilation Mask
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- SPO2
研究概览
简要总结
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
详细描述
20 participants will be included in the study. The number of patients for each group is 5.
The trial is, a crossover trial, as all participants go through every one of the trial conditions, albeit in a different order, and thus every trial condition will have results of 20 patients in it eventually.
Prior to patient treatment, the subject will be informed about the study and potential risks, and will be givin written informed consent.
Prior to every inhalation and particle sampling, a baseline sample will be taken to filter possible carryovers from previous sampling.
Demographics including age, sex, DOB, height, weight and body mass index. Past medical history including smoking status, co-morbid conditions and medication use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Male and female adults, aged 18 years and over.
- •Suffering from hypoxemic and/or hypercarbic respiratory failure requiring non-invasive ventilation and selected by medical staff to use CPAP or BiPAP.
- •Fully concious (Glasgow Coma Scale 14-15) and able to cooperate with non-invasive ventilation.
- •Able to provide informed consent to participate in the study.
- •Have an active arterial line in place for arterial blood sampling (arterial lines will not be placed for the sole purpose of the study). Alternatively, IV line can be used.
排除标准
- •Age < 18 years.
- •Respiratory failure due to non-pulmonary pathology.
- •Presence of a contraindication to the use of non-invasive ventilation or an absolute indication for invasive ventilation.
- •Presence of a facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face.
- •Hemodynamic instablity.
- •Severe upper gastrointestinal bleeding.
- •Chest trauma.
- •Claustrophobia
结局指标
主要结局
SPO2
时间窗: Up to 30 minutes post ventilation
Precentage of SPO2 post ventilation
Serum Lactate
时间窗: Up to 30 minutes post ventilation
Serum Lactate post ventilation measured in mmol/Lit
Respiratory Rate
时间窗: during ventilation
Measuring of Respiratory Rate in breaths per minute, during ventilation
pH
时间窗: Up to 30 minutes post ventilation
logarithmic units of pH post ventilation
pO2
时间窗: Up to 30 minutes post ventilation
mmHg of PO2 post ventilation
pCO2
时间窗: Up to 30 minutes post ventilation
pCO2 post ventilation measured in mmHg
Adverse Events
时间窗: From date of study randomization until the end of treatment per each patient, up to 30 min post ventilation
Number of patients related Adverse Events as assessed by CTCAE v5.0
HCO3
时间窗: Up to 30 minutes post ventilation
HCO3 post ventilation measured in mEq/L
次要结局
- Room aerosol concentration(Before ventilation and during ventilation)
- Use comfort(Up up 1 hour post ventilation)