High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Dyspnea Numeric Score Between 0 and 10 Minutes
研究概览
简要总结
The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air in helping to decrease shortness of breath in cancer patients. Researchers also want to learn if these therapies can help to improve lung function and quality of life.
详细描述
Study Groups and Procedures:
If you agree to take part in this study, you will receive 4 different breathing therapies:
- High-flow oxygen
- Low-flow oxygen
- High-flow air and
- Low-flow air
The order in which they will be given to you will be randomly assigned (as in a roll of dice). You will have an equal chance of being assigned to each group. Neither you nor the study staff will know which therapy order you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving.
All 4 breathing therapies should take about 80 minutes total to complete (10 minutes for each treatment with a 10 minute break between each treatment). You will receive the air or oxygen through small tubes placed in your nose. The respiratory therapist will be there to adjust the therapy to your comfort level.
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
- Double (Participant, Investigator)
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
- •Diagnosis of cancer
- •Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center
- •Dyspnea Numeric Rating Scale at rest >/=3 of 10 (average over last 24 hour)
- •Non-hypoxemic (i.e. oxygen saturation >90% on ambient air)
- •Able to communicate in English or Spanish
- •Age >/= 18 years
- •Able to tolerate high-flow oxygen/air
排除标准
- •Memorial Delirium Rating Scale >13
- •Hemodynamic instability
- •Respiratory failure requiring mechanical ventilation or non-invasive ventilation
- •Frequent use of rescue opioids >8x/day or rescue bronchodilators >8x/day over last 24 hours
- •Currently requiring high flow oxygen for oxygenation
结局指标
主要结局
Change in Dyspnea Numeric Score Between 0 and 10 Minutes
时间窗: 0 (baseline) minutes and at 10 minutes
We assessed dyspnea intensity 'now' using a numeric rating scale from 0 to 10 where 0=none and 10=worst. The minimal clinically important difference was 1 point.
次要结局
- Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes(0 (baseline) minutes and at 10 minutes)
- Change in Modified Borg Scale Intensity Between 0 and 10 Minutes(0 (baseline) minutes and at 10 minutes)