NCT02278107Unknown不适用
Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
New Aera, Inc0 个研究点目标入组 20 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Exercise Endurance Time to Maximum Tolerance
研究概览
简要总结
A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.
详细描述
An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Adult male or female (> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
- •Participates in a qualified pulmonary rehabilitation program
- •Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
- •Able and willing to sign the informed consent
- •Ability to be fitted with the test nasal mask and to use the test ventilator system
排除标准
- •Requires > 5LPM of constant flow to maintain SpO2> 90% during exercise
- •Reports having serious epistaxis within the last 14 days prior to enrollment
- •Currently enrolled in another clinical study or has participated within 30 days of enrollment
- •Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data
结局指标
主要结局
Exercise Endurance Time to Maximum Tolerance
时间窗: Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort).
次要结局
- Borg 10 Dyspnea Score, Subject reported(Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.)
- Arterial Oxygen Saturation via Pulse Oximeter (SpO2)(Recorded 1-2 min before and every 1 minute during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.)
- Heart Rate(Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.)
- Leg Fatigue, Subject Reported(Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.)
- Adverse Events(Two 4-hr study visits, sheduled 1 week apart. Subjects will be monitored for AEs continuously throughuout the study visit. AEs will be monitored and recored during both study visits.)
- Respiratory Rate(Recorded 1-2 min before and every 1 min during exercise. Evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.)
研究者
相似试验
已完成
不适用
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep ApneaObstructive Sleep ApneaNCT04011826Fisher and Paykel Healthcare45
已完成
不适用
Nasal Noninvasive NAVA in the Very Low Birth Weight InfantInfant, Very Low Birth WeightPulmonary Ventilation, Newborn InadequateNCT01785563Tarah T Colaizy40
招募中
不适用
Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung UltrasoundPretermVentilator Lung NewbornNCT06550219Alexandria University30
撤回
不适用
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep ApneaObstructive Sleep ApneaNCT04063436Fisher and Paykel Healthcare
已完成
不适用
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep ApneaObstructive Sleep ApneaNCT03124069Fisher and Paykel Healthcare37