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

NCT ID: NCT05416437

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-06-30

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.

Conditions

Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device arm

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

Group Type: ACTIVE_COMPARATOR

PneumoCool

Intervention Type: DEVICE

Device to channel medical air to the patient to alleviate dyspnea

Standard of Care arm

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: OTHER

a room fan, or any other currently used supportive measures can be used for patients in the control arm

Interventions

PneumoCool

Device to channel medical air to the patient to alleviate dyspnea

Intervention Type: DEVICE

Current 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Sonal Pannu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonal R Pannu, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2021H0334

Identifier Type: -

Identifier Source: org_study_id