Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Efficacy of 3 Different Oxygen Delivery Methods
研究概览
简要总结
The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control shortness of breath.
详细描述
Device A is designed to get more air in and out of their lungs without using as much effort as regular breathing. The air is given through a mask, and the amount of air can be set to different levels.
Device B is designed to deliver air in and out of the lungs. The air is warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.
Device C is designed to deliver air in and out of the lungs. The air is given through a mask, and the amount of air can be set to different levels.
Study Groups and Device Use:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:
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 advanced cancer, defined as locally advanced, recurrent, or metastatic disease
- •Persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level >=3/10 on the numeric rating scale for at least 1 week and just prior to study initiation despite supplemental oxygen for at least 30 minutes
- •Dyspnea judged clinically to be predominantly due to the underlying malignancy, with or without obstructive lung disease
- •Inpatient at MD Anderson Cancer Center
- •Able to communicate in English
- •Expected life expectancy >1 week
- •Age 18 or older
排除标准
- •Hypoxia (i.e., O2 saturation <90%) despite supplemental oxygen at 15 L/min
- •Hemodynamic instability (systemic blood pressure (SBP) <90 mmHg) within 1 hour of study initiation
- •Comatose state or delirium, as indicated by a Memorial Delirium Assessment Scale score of 13 or higher
- •Uncontrolled arrhythmia as per clinical record at enrollment
- •Upper GI bleeding within 2 weeks of enrollment
- •Esophageal rupture at enrollment
- •Upper airway obstruction at enrollment
- •History of facial trauma within 2 weeks of enrollment
- •Facial, upper airway, or GI surgery within 2 weeks of enrollment
- •Thoracic surgery within 6 weeks of enrollment
- •Excessive airway secretions interfering with BiPAP administration
- •Undrained pneumothorax at enrollment
- •Partial or complete small bowel obstruction or severe nausea/vomiting (Edmonton symptom assessment scale nausea >7/10) within 48 hours of enrollment
- •Hemoglobin <8 g/dL at the time of enrollment (blood drawn within past 2 weeks)
- •Acute exacerbation of chronic obstructive pulmonary disease (COPD) or heart failure within 1 week of enrollment by history or physical
- •Known CO2 retainers as per clinic station
- •Known pulmonary hypertension as per clinic station
- •Unwillingness to provide consent
结局指标
主要结局
Efficacy of 3 Different Oxygen Delivery Methods
时间窗: 6 hours
Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).
次要结局
未报告次要终点