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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dyspnea
• Intervention / Treatment: Device: PneumoCool; Other: Current supportive measures that are used in the hospital for standard of care

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device arm; The patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea	Device: PneumoCool; Device to channel medical air to the patient to alleviate dyspnea
Placebo Comparator: 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	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Sonal R Pannu, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: 2021H0334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No