Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience (BREATHE-easy)

The Ohio State University

Status: Active, not recruiting

Conditions: Dyspnea

Treatments: Device: PneumoCool; Other: Current supportive measures that are used in the hospital for standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05416437

2021H0334

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Device arm

Active Comparator group

Description:

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

Treatment:

Device: PneumoCool

Standard of Care arm

Placebo Comparator group

Description:

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

Treatment:

Other: Current supportive measures that are used in the hospital for standard of care