Dyspnea
Conditions
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.
Interventions
DEVICEPneumoCool
Device to channel medical air to the patient to alleviate dyspnea
OTHERCurrent supportive measures that are used in the hospital for standard of care
a room fan, or any other currently used supportive measures can be used for patients in the control arm
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The is an open label study. There is no masking
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing) | 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
| Measure | Time frame | Description |
|---|---|---|
| Supplemental oxygen | At 48 hours after study enrollment | change of supplemental oxygen |
| External cooling devices | From enrollment to hospital discharge or 30 days whichever happens earlier | Duration of external cooling devices (hours) |
| Bronchodilator dosage | At 48 hours after study enrollment | Mean changes in Bronchodilator doses |
| Benzodiazepine dosage | At 48 hours after study enrollment | Mean changes in Benzodiazepine doses |
| Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath) | At 8 hours after enrollment | Mean Change visual analog scale |
| Bedside provider calls for dyspnea | At 48 hours after study enrollment | Mean changes in bedside provider calls for dyspnea |
| 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 | Note the need for Noninvasive positive pressure ventilation \[NPIIV\] or Invasive mechanical ventilation |
| Hospital length of stay | Upto hospital discharge or death which every happens earlier upto 60 day after enrollment | Note duration of hospitalization |
| ICU length of stay | Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment | Note duration of ICU stay for those patients in the ICU |
| Opoid dosage | At 48 hours after study enrollment | Mean changes in Opoid doses |
Countries
United States
Outcome results
None listed