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

NCT05416437 | Active Not Recruiting

• 1 other identifier: 2021H0334
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)

  At 8 hours after enrollment

• Supplemental oxygen

  At 48 hours after study enrollment

• External cooling devices

  From enrollment to hospital discharge or 30 days whichever happens earlier

• Bronchodilator dosage

  At 48 hours after study enrollment

• Benzodiazepine dosage

  At 48 hours after study enrollment

Study Arms (2)

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

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

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

Interventions

PneumoCool DEVICE

Device to channel medical air to the patient to alleviate dyspnea

Device arm

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

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

Standard of Care arm

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sonal R Pannu, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The is an open label study. There is no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: June 15, 2022
• Primary Completion: July 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)