PneumoCool Device for Shortness of Breath

(BREATHE-easy Trial)

Overseen By Sarah Karow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Delirium, Dementia, Brain injury, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to hospital discharge or 30 days, whichever happens earlier

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the PneumoCool treatment for shortness of breath?

Research on similar devices, like oscillating positive expiratory pressure (OPEP) devices, shows they can help clear mucus and improve symptoms in people with chronic obstructive pulmonary disease (COPD). This suggests that the PneumoCool treatment might also be effective in reducing shortness of breath by helping clear airways. ^{1 2 3 4 5}

How does the PneumoCool treatment for shortness of breath differ from other treatments?

The PneumoCool treatment is unique because it likely involves a novel device for delivering therapy, potentially similar to advanced nebulizers or aerosol devices that enhance drug delivery to the lungs. This could mean more efficient treatment with better control over dosage and improved patient outcomes compared to traditional methods. ^{6 7 8 9 10}

Research Team

Sonal R Pannu, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for adults over 18 who are hospitalized with expected stays longer than a day and experiencing significant shortness of breath. It's not suitable for patients with delirium, dementia, brain injuries that prevent consent or device use, those on continuous mechanical ventilation, or prisoners.

Inclusion Criteria

I am admitted to the specified hospital and will stay for more than a day.

I often feel short of breath.

Exclusion Criteria

I rely on a machine to help me breathe all the time.

You have a condition that affects your ability to think clearly or remember things.

I cannot use the device due to my motor disability.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the PneumoCool device or usual therapy to alleviate dyspnea

Up to hospital discharge or 30 days, whichever happens earlier

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 days after enrollment

Treatment Details

Interventions

• PneumoCool

Trial Overview The BREATHE-easy trial is testing the PneumoCool device against standard hospital care to see if it better relieves shortness of breath in patients. Participants will be randomly assigned to either receive this new bladeless air device or continue with usual supportive measures.

Participant Groups

Group I: Device arm Active Control 1 Intervention

The patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea

Group II: Standard of Care arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Adjuncts for sputum clearance in COPD: clinical consensus versus actual use. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of oscillating positive expiratory pressure therapy in stable chronic obstructive pulmonary disease. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Use of Airway Clearance Devices in the Management of Chronic Obstructive Pulmonary Disease. A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Use of oscillatory positive expiratory pressure (OPEP) devices to augment sputum clearance in COPD: a systematic review and meta-analysis. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Aerosol bronchodilator administration in ventilator circuits. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Early experience with a vertical spinning-disc nebuliser. [2015]

8. Japan pubmed.ncbi.nlm.nih.gov

Usefulness of a 4-Grade Novel Mouthpiece Device for Increased Mouth Pressure Reproducing Artificial Difficulty in Breathing. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The Blo-Bag, a disposable spacer. [2013]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A new aerosol device for bronchial provocation tests. [2018]