Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience

Conditions
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Dyspnea

Intervention / Treatment
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* Device: PneumoCool
* Other: Current supportive measures that are used in the hospital for standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device arm<br>The patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea | Device: PneumoCool<br>* Device to channel medical air to the patient to alleviate dyspnea<br>|
| Placebo Comparator: Standard of Care arm<br>The patients in the standard of care arm can get a fan or any other supportive care that is currently available in the hospital for alleviating dyspnea | Other: Current supportive measures that are used in the hospital for standard of care<br>* a room fan, or any other currently used supportive measures can be used for patients in the control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing) | Mean changes in the Borg Dyspnea scale (0 indicating no effort of breathing, 10 indicating maximal effort of breathing) | At 8 hours after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath) | Mean Change visual analog scale | At 8 hours after enrollment | 
| Supplemental oxygen | change of supplemental oxygen | At 48 hours after study enrollment | 
| External cooling devices | Duration of external cooling devices (hours) | From enrollment to hospital discharge or 30 days whichever happens earlier | 
| Bronchodilator dosage | Mean changes in Bronchodilator doses | At 48 hours after study enrollment | 
| Benzodiazepine dosage | Mean changes in Benzodiazepine doses | At 48 hours after study enrollment | 
| Opoid dosage | Mean changes in Opoid doses | At 48 hours after study enrollment | 
| Bedside provider calls for dyspnea | Mean changes in bedside provider calls for dyspnea | At 48 hours after study enrollment | 
| Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation) | Note the need for Noninvasive positive pressure ventilation [NPIIV] or Invasive mechanical ventilation | Upto hospital discharge or death which every happens earlier upto 60 day after enrollment | 
| Hospital length of stay | Note duration of hospitalization | Upto hospital discharge or death which every happens earlier upto 60 day after enrollment | 
| ICU length of stay | Note duration of ICU stay for those patients in the ICU | Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment |