A prospective, post market, non-interventional observational, open label, single arm, single center study to confirm clinical safety and performance of SkanRespiro Plus and Pranaa
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition.
研究概览
简要总结
SkanRespiro Plus is a paediatric and adult critical care ventilator intended to provide short term continuous mechanical ventilation. It is capable of delivering pneumatically induced breaths based on set parameters and proactively monitors respiratory parameters. Pranaa is a medical air compressor which acts as an accessory for ICU or anesthesia ventilator. It provides the dry, compressed and filtered air to the ventilator. This clinical study is being conducted to confirm the clinical safety and performance of SkanRespiro Plus and Pranaa. This study will generate the clinical evidence to support the claimed intended use.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult and pediatric subjects of age more than two year or body weight of 10 kg above whichever is lower and of either gender.
- •Subjects who need mechanical ventilation.
- •Subject or the legally authorised representative on behalf of subject shall be capable of understanding and signing the informed consent form.
排除标准
- •Subjects with age less than two year or less than 10 kg of body weight.
- •Subjects who need ventilation during transport.
- •Pregnant or nursing mother.
- •Unconscious subjects shall be excluded from the non invasive mode of ventilation.
结局指标
主要结局
Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition.
时间窗: Every 4 hours
次要结局
- Collection of feedback which includes investigator’s assessment of the overall safety and performance of the SkanRespiro Plus and Pranaa.(Collection of feedback from the user reflecting the ease of ventilation and usability.)