An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Completing Study Intervention
研究概览
简要总结
The goal of this clinical research study is to learn if specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of breath. Researchers want to learn if these devices can help to control shortness of breath.
The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure) and Vapotherm.
详细描述
Study Devices:
The BiPAP device is designed to help people 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.
The Vapotherm device is also 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.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
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
- 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
- •History of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- •Patients with persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level >/=3 out of a Numeric Rating Scale from 0 to 10 for at least 2 week and just prior to study initiation, despite supplemental oxygen of up to 21 L/min to keep oxygen saturation >/=90%
- •Dyspnea is judged clinical to be predominantly due to underlying malignancy, with or without obstructive lung disease
- •Inpatient at MD Anderson Cancer Center
- •Patients with cancer treatment related dyspnea are eligible for this study if they meet the eligibility criteria above.
- •Able to communicate in English
- •Expected life expectancy >1 week
- •Patients with a diagnosis of pneumonia are also eligible for this study if they meet the eligibility criteria above, with dyspnea >=2 weeks prior to the diagnosis of pneumonia.
- •Age 18 or greater
排除标准
- •Patients who remain hypoxic (i.e. O2 saturation <90% despite maximal oxygen delivery (21 L/min) are not included in this study because they are considered to have severe life-threatening respiratory failure and are too unstable for study inclusion.
- •Hemodynamic instability (Heart Rate (HR) >140, systolic blood pressure (SBP) <80) within 24 hours of study initiation (as per Clinic Station)
- •Acute respiratory distress requiring intubation
- •Delirium as indicated by a Memorial Delirium Assessment Scale (MDAS) of 13 or higher
- •Glasglow coma scale <8
- •Excessive airway secretions interfering with BIPAP administration
- •History of facial trauma within 1 month of enrollment
- •Upper GI bleed within 2 weeks of enrollment or esophageal rupture
- •Partial or complete small bowel obstruction or severe nausea/vomiting (ESAS nausea >7/10) within 48 hours of enrollment
- •Hemoglobin <8 g/dL at the time of enrollment (blood draw within last 2 weeks)
- •Acute exacerbation of COPD or CHF within 2 weeks of enrollment by history or physical
- •Unwilling to provide informed consent
- •Diagnosis of non-cancer related dyspnea (e.g. Chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF) or any chronic respiratory disease) requiring supplemental home oxygen prior to hospitalization.
结局指标
主要结局
Number of Participants Completing Study Intervention
时间窗: Minimally 1 hour, up to 5 hours
Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study. A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was \>/= baseline dyspnea level-1, or (2) their dyspnea level was \>/= 3/10 after one hour.
Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale
时间窗: Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)
Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.
次要结局
未报告次要终点