Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dyspnea
- Sponsor
- Ohio State University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Sonal Pannu
Principal Investigator
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
Time Frame: At 8 hours after enrollment
Mean changes in the Borg Dyspnea scale (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
Secondary Outcomes
- 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)