Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
研究概览
简要总结
The BREATHE-easy is a randomized control trial assessing the efficacy of the novel PneumoCool device to alleviate subjective shortness of breath. The PneumoCool device is a disposable, bladeless, highly portable device that uses medical-grade air that confers many advantages in a hospital setting.
详细描述
This will be randomized control trial (RCT) for patients admitted to the Ohio State University Wexner Medical Center, ROSS and James Cancer Hospital. Patients will be screened to assess eligibility. The study team will use a 2-group (intervention vs. control) RCT design. On meeting inclusion criteria, completed informed consent will be obtained. After informed consent, subjects will be randomized to receive either the PneumoCool device or usual therapy. PneumoCool setup will be done by the study team. This study will be unblinded, since blinding is not feasible in this device study. Conventional therapy will include the patients usual care and any palliation for patients' symptoms ordered by the primary team, including bedside fan if the patient requests. Patients will be queried for their symptoms at the time of enrollment, at time 0 (start of first arm of trial) and 8 hours for the primary outcome. Patient will be followed throughout their hospital stay until discharge. Data will be collected from the electronic medical record. Patient and Provider satisfaction will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The is an open label study. There is no masking
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyspnea (Borg Scale > 3)
- •Admitted to University hospital, ROSS or James Cancer Hospital with expected length of stay > 24 hours
- •Age 18 years or more
排除标准
- •Delirium (assessed by CAMICU) or dementia or brain injury precluding ability to consent and or respond to outcome scales
- •Prisoner status
- •Continuous mechanical ventilation
- •Patients with motor disability with inability to maneuver the device
结局指标
主要结局
Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
时间窗: At 8 hours after enrollment
Mean changes in the Borg Dyspnea scale (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
次要结局
- Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)(At 8 hours after enrollment)
- Supplemental oxygen(At 48 hours after study enrollment)
- Opoid dosage(At 48 hours after study enrollment)
- Hospital length of stay(Upto hospital discharge or death which every happens earlier upto 60 day after enrollment)
- Bronchodilator dosage(At 48 hours after study enrollment)
- External cooling devices(From enrollment to hospital discharge or 30 days whichever happens earlier)
- Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation)(Upto hospital discharge or death which every happens earlier upto 60 day after enrollment)
- ICU length of stay(Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment)
- Benzodiazepine dosage(At 48 hours after study enrollment)
- Bedside provider calls for dyspnea(At 48 hours after study enrollment)
研究者
Sonal Pannu
Principal Investigator
Ohio State University