Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
研究概览
简要总结
This study is meant to compare the amount of oxygen required for hypoxemia relief between current standard of care (oxygen only) and oxygen with the addition of high flow air for Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), and Pulmonary Hypertension (PH) patients during rest. Subjects will be titrated from 0 L/min until they maintain 95% SpO2 for each of the following delivery methods:
- Pulses of pure oxygen (control)
- Constant high flow air with pulses of pure oxygen
- Out of phase pulses of high flow air and pure oxygen
详细描述
Each participant will require (1) visit, which will last approximately 4-5 hours.
At start of visit:
- Vitals are taken (temperature, heart rate, SpO2, respiration rate, blood pressure, Borg dyspnea score, Mmrc score) while participant is seated and using their normal oxygen prescription.
- Patient will remain seated during the following procedure with SpO2 and heart rate continuously being monitored.
Pulsed Oxygen Control at Rest:
- Participant's oxygen will be turned off for 10 minutes as a washout period.
- Using the oxygen tank with the pulse regulator, the participant will be titrated to a pulse rate that maintains their SpO2 at an average of 95%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Order of treatments tested will be randomized and only known to the person administering the study.
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged greater or equal to 30 years old
- •Require Long Term Oxygen Therapy between 1 L/min and 4 L/min while at rest
- •Have a peripheral blood saturation level above 80% with room air while seated
- •Tolerate breathing while seated in room air
- •Diagnosed with one of the following respiratory diseases: COPD (40% < Forced Expiratory Volume (FEV1) < 80% confirmed from pulmonary function test (PFT) within the last year), ILD (Confirmed with radiographic imaging), PH (Confirmed with radiographic imaging)
- •Normal heart rate and blood pressure (Resting Heart Rate <120 bpm, Systolic BP <180 mmHg, Diastolic BP <100mmHg)
- •PFT taken in the last three months
排除标准
- •Pregnancy or lactation
- •Exacerbation that has resolved within the past 28 days
- •Treatment with another investigational drug or other intervention within three months
- •Has any of the following: unstable angina, recent revascularization, recent history of cerebrovascular accident
结局指标
主要结局
Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
时间窗: up to 20 minutes
This will be assessed using the difference between the oxygen delivery systems (pure oxygen and mixed high-flow air with oxygen) in the L/min flow of oxygen required for a participant to reach steady state at greater than or equal to 95% pulse oxygenation.
次要结局
- Dyspnea relief achieved with of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy(Approximately 15 minutes)