DyspneaBREATHE-easyNCT05416437
Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
A study testing PneumoCool in people with Dyspnea, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- PneumoCool
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dyspnea
- Being tested
- PneumoCool, Current supportive measures that are used in the hospital for standard of care
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumoCoolDevice
Device to channel medical air to the patient to alleviate dyspnea
Current supportive measures that are used in the hospital for standard of careOther
a room fan, or any other currently used supportive measures can be used for patients in the control arm
| Study group | Role | What they receive |
|---|---|---|
| Device arm | Active comparator | The patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea Receives: Device: PneumoCool |
| Standard of Care arm | Placebo comparator | 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 Receives: Other: Current supportive measures that are used in the hospital for standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 8 hours after enrollment
Secondary outcomes (10)
Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)
Mean Change visual analog scale
Measured: At 8 hours after enrollment
Supplemental oxygen
change of supplemental oxygen
Measured: At 48 hours after study enrollment
External cooling devices
Duration of external cooling devices (hours)
Measured: From enrollment to hospital discharge or 30 days whichever happens earlier
Bronchodilator dosage
Mean changes in Bronchodilator doses
Measured: At 48 hours after study enrollment
Benzodiazepine dosage
Mean changes in Benzodiazepine doses
Measured: At 48 hours after study enrollment
Opoid dosage
Mean changes in Opoid doses
Measured: At 48 hours after study enrollment
Bedside provider calls for dyspnea
Mean changes in bedside provider calls for dyspnea
Measured: 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
Measured: Upto hospital discharge or death which every happens earlier upto 60 day after enrollment
Hospital length of stay
Note duration of hospitalization
Measured: 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
Measured: Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start15 Jun 2022
- Primary completion30 Jul 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonal Pannu, Ohio State University
- Investigators
- Sonal R Pannu, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416437
- Sponsor's protocol ID
- 2021H0334
- Acronym
- BREATHE-easy
- Status last verified
- Apr 2025
- First submitted
- 8 Jun 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
- ClinicalTrials.gov ID
- NCT05416437
- Acronym / sponsor ID
- BREATHE-easy / 2021H0334
- Conditions
- Dyspnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Device arm | Active comparator | Device: PneumoCoolThe patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea |
| Standard of Care arm | Placebo comparator | Other: Current supportive measures that are used in the hospital for standard of careThe 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 may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PneumoCoolDevice to channel medical air to the patient to alleviate dyspnea | Device | Device arm |
| Current supportive measures that are used in the hospital for standard of carea room fan, or any other currently used supportive measures can be used for patients in the control arm | Other | Standard of Care arm |
Primary outcome
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)
10 secondary outcomes
Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)
Time frame: At 8 hours after enrollment
Supplemental oxygen
Time frame: At 48 hours after study enrollment
External cooling devices
Time frame: From enrollment to hospital discharge or 30 days whichever happens earlier
Bronchodilator dosage
Time frame: At 48 hours after study enrollment
Benzodiazepine dosage
Time frame: At 48 hours after study enrollment
Opoid dosage
Time frame: At 48 hours after study enrollment
Bedside provider calls for dyspnea
Time frame: At 48 hours after study enrollment
Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation)
Time frame: Upto hospital discharge or death which every happens earlier upto 60 day after enrollment
Hospital length of stay
Time frame: Upto hospital discharge or death which every happens earlier upto 60 day after enrollment
ICU length of stay
Time frame: Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonal R Pannu, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PneumoCool in people with Dyspnea, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing) (time frame: At 8 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.