Clinical Efficacy of the Indigenously Developed High Flow Nasal Cannula Device (TrueOxy+ HFNC Device): A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- 1. Agreement between measured and predicted arterial partial pressure of oxygen PaO2 for each FiO2 percentage change
研究概览
简要总结
This study aims to investigate clinical efficacy of the Indigenously Developed High Flow Nasal Cannula Device (TrueOxy+ HFNC Device) on the healthy individuals. The prime clinical benefit of this HFNC is its efficiency in delivering supplemental oxygen with humidification and at higher flows which satisfy the patients’ peak inspiratory flow rate. The performance of this device in this trial will enable the production of an indigenously developed low-cost HFNC device which will be potentially cost saving to several hospitals while providing clinical benefit to the patients. This study aims to clinically test this device on healthy volunteers to demonstrate its efficacy in increasing the oxygenation at various flow rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy men and women aged between 20-50 years
- •Willing to give written, informed consent
- •Willing to comply with protocol requirements
- •Normal physical & systemic examination
- •Have normal hemogram and renal function test in the past 6 months
- •BMI 18 to 30
- •Non-smokers and no history of respiratory disease.
排除标准
- •1.Elderly, above 50 years 2.Known respiratory disease 3.Recent less than 3 months mechanical ventilation ICU, hospital admission 4.Anemia 5.History of Hemoglobinopathy, sickle cell disease, thalassemia 6 Positive pregnancy test, females 7.Significant cardiac or pulmonary disease 8.History of sleep apnea 9.Tobacco, drug or alcohol abuse 10.Difficult airway 11.Abnormal ekg, pulmonary function test, room air saturation 12.Intolerance to HFNC apparatus 13.Participation in Phase I study in previous 6 months or in Phase 2 or 3 studies in previous 3 months.
结局指标
主要结局
1. Agreement between measured and predicted arterial partial pressure of oxygen PaO2 for each FiO2 percentage change
时间窗: At Baseline and after 20 minutes for all 4 sessions intervention sessions mentioned in study protocol
次要结局
- Change in vital parameters (HR, BP, SpO2, RR) at the end of each session from baseline
- Proportion of patients experiencing adverse and serious adverse events.(every 5 minutes from start of intervention till 1 hour after the end of intervention.)
研究者
Dr Shiv Lal Soni
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh