Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia Acute Testing of Oxygen Demand Using TNI® vs. Standard Insufflation in COPD Patients With Hypercapnia at Rest
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- PaO2
研究概览
简要总结
Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and hypercapnia.
Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients with hypercapnia.
详细描述
TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely comfortable and uncomplicated alternative to numerous other approaches in non-invasive ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated complications as patients could not tolerate high airflow delivered by a thin nasal cannula without humidification and warming, thus causing concomitant negative effects. The new therapy TNI shows a high rate of acceptance by children, too.
At present, there are two different types of devices available for nasal insufflation in clinics:
TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier for clinical compressed air, which can be combined with oxygen.
TNI 20 oxy The system, which is unique throughout the world, is optimized for the application of flows of up to 20L/min and fulfils the minimum requirements of the "American Society of Testing and Materials" for a high flow air humidifier in the non-invasive application of 10 mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient temperature. Condensation is prevented in the nasal applicator by heating the tube as far as the nostrils. The device automatically controls humidity and temperature depending on the prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by means of a standard pressure regulator.
In another ongoing study (STIT-1) TNI 20 oxy was evaluated for its safety in COPD patients without hypercapnia. In a first interim analysis which included 14 patients high flow oxygen delivery was safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients with an indication for long-term oxygen therapy (LTOT)
- •Presence of hypercapnia at rest without oxygen supplementation (PaCO2 > 45 mmHg)
- •Age 30 - 85 years
- •Functional GOLD class: COPD GOLD IV as defined by the following:
- •FEV1/FVC < 70% and a Post-bronchodilator FEV1 < 30% or FEV1 < 50% and a PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg
排除标准
- •Clinical instability of the patient
- •No lung function testing possible
- •Exacerbation within the last 14 days prior to inclusion into the study
- •Serious concomitant diseases that may jeopardize the inclusion of the patient into the study from the investigator's point of view
- •Severe anaemia, defined by a haemoglobin <8.5 G/L
- •Participation of the patient in any other ongoing study
结局指标
主要结局
PaO2
时间窗: 60 min
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
次要结局
- O2%(60 min)
- PaCO2(60 min)
- AaDO2(60 min)
- RV and TLC(60 min)
研究者
Univ.-Prof. Dr. Christian M. Kaehler
a.Univ.-Prod. Dr.
Medical University Innsbruck