Feasibility of Using a Home-Based High Frequency Chest Wall Oscillation Device (AffloVest) in At-Risk Respiratory Patients to Decrease Acute Respiratory Care Burden During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in forced expiratory volume in one second (FEV1)
研究概览
简要总结
The purpose of the study is to investigate the addition of high frequency chest wall oscillation (HFCWO) therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.
详细描述
Thirty study participants in New York City who meet inclusion criteria will be recruited from Mount Sinai's COVID-19 Post-Recovery Center of Excellence and Respiratory Institute. Fifteen subjects (determined by the last digit of their medical record number) will receive a HFCWO device (AffloVest), digital thermometer, pulse oximeter, and spirometer at their home. Participants will be trained remotely to use the AffloVest and spirometer. In addition all subjects will be asked to complete a series of online mental health and respiratory symptom assessments via REDCap. A 15 patient control group meeting inclusion criteria will be recruited from the Mount Sinai COVID-19 Post-Recovery Center of Excellence and Respiratory Institute using the same screening process. This group will not receive the HFCWO intervention but will receive a digital thermometer, pulse oximeter, and spirometer at their home (with training via telehealth), asked to complete all REDCap and respiratory symptom assessments. Consent for both groups will be obtained by a Mount Sinai clinician-researcher.
Study Duration Approximately 30 days plus 60 and 90-day check in
Objectives To investigate the addition of HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician and data analysts will be blinded to treatment cohort.
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 males and females ≥18 years
- •Existing diagnosis of COPD for >6 months
- •Chronic productive cough
- •Radiographic evidence of flattening of the diaphragm
- •Prior COVID-19 diagnosis
- •Clinically followed by Mount Sinai COVID-19 Post Recovery and Respiratory Institute.
- •Ability to provide informed consent
- •Ability to read and fill out survey questionnaires via REDCap (surveys will be available in English and Spanish)
- •Access to a home computer, tablet, or smartphone
排除标准
- •Presenting with hypoxia (02 sat <90%)
- •Acute COVID-19 infection
- •Home oxygen dependent
- •Established diagnosis of cystic fibrosis
- •History of osteoporosis or rib fracture
- •Active Hemoptysis
- •Pneumothorax
结局指标
主要结局
Change in forced expiratory volume in one second (FEV1)
时间窗: Baseline and up to 90 Days
Change in forced expiratory volume in one second (FEV1) as compared to baseline, measured by home spirometer.
Change in Presence of Fever
时间窗: Baseline and up to 90 Days
Changes in basal temperature as measured by digital thermometer. Fever is indicated at 100.4 F (38 C) or higher.
Change in Oxygen Saturation level
时间窗: Baseline and up to 90 Days
Changes in oxygen saturation from baseline as measured by pulse oximeter. Normal oxygen range is 95 to 100 percent and low oxygen range is under 90 percent.
次要结局
- Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)(Baseline and up to 90 Days)
- Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire(Baseline and up to 90 Days)
- AffloVest Usage(90 Days)
- Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)(Baseline and up to 90 Days)
- Change in COVID Symptom Checklist(Baseline and up to 90 Days)
- Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)(Baseline and up to 90 Days)
研究者
Patricia Walker
Co-Director, The Cystic Fibrosis Center
Icahn School of Medicine at Mount Sinai