A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Device easiness-to-use
研究概览
简要总结
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.
The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.
详细描述
The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Age ≥65 years
- •Clinically stable: non-hospitalized and not in acute illness
- •no professional medical knowledge: no experience as a health care provider
- •Ability to express informed consent as requested by the ethical committee
排除标准
- •Inclusion Criteria:
- •Hospitalized adult patient
- •SpO2 of 90-93% in room air
- •Exclusion Criteria:
- •Facial burns/trauma/recent facial or upper airway surgery
- •Fixed upper airway obstruction
- •Undrained pneumothorax
- •Recent upper gastrointestinal surgery
- •Inability to protect the airway
- •Bowel obstruction
- •Patient refusal
研究组 & 干预措施
Healthy elderly individuals
The performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device.
干预措施: Portable CPAP usability assessment (Device)
Patients with mild oxygenation impairment
The efficacy of the device will be assessed in patients with mild oxygenation impairment.
干预措施: Portable CPAP efficacy (Device)
结局指标
主要结局
Device easiness-to-use
时间窗: Up to 2 hours
Volunteers in self-experience tests will be asked to assign a score depending on the easiness-to-use of the device and comfort during the device operation. A semantic differential scale will be used between "hard to use" (corresponding to the score 1) and "easy to use" (corresponding to the score 5). The best result is represented by a higher score, with 5 being the highest and 1 the lowest.
Duration of proper pressure delivery
时间窗: Up to 2 hours
Total time of target pressure (4 - 15 cmH2O) during 15-min test
Battery power consumption and duration
时间窗: Up to 2 hours
We will set 15 minutes of continuous device operation as an efficacy threshold and will assess the battery status at the end of each experiment.
Change in SpO2 level
时间窗: Up to 2 hours
Change in SpO2 before and during the device application
次要结局
未报告次要终点
研究者
Giovanni Landoni
Director of the Research Center for Intensive Care and Anesthesiology of San Raffaele Scientific Institute
IRCCS San Raffaele