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

Not Applicable

Active, not recruiting

• Conditions: Dyspnea

• Registration Number: NCT05416437
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2022-06-15
• Primary Completion: 2024-07-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)	At 8 hours after enrollment	Mean changes in the Borg Dyspnea scale (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)

Secondary Outcome Measures

Name	Time	Method
Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)	At 8 hours after enrollment	Mean Change visual analog scale
Supplemental oxygen	At 48 hours after study enrollment	change of supplemental oxygen
Opoid dosage	At 48 hours after study enrollment	Mean changes in Opoid doses
Hospital length of stay	Upto hospital discharge or death which every happens earlier upto 60 day after enrollment	Note duration of hospitalization
Bronchodilator dosage	At 48 hours after study enrollment	Mean changes in Bronchodilator doses
External cooling devices	From enrollment to hospital discharge or 30 days whichever happens earlier	Duration of external cooling devices (hours)
Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation)	Upto hospital discharge or death which every happens earlier upto 60 day after enrollment	Note the need for Noninvasive positive pressure ventilation \[NPIIV\] or Invasive mechanical ventilation
ICU length of stay	Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment	Note duration of ICU stay for those patients in the ICU
Benzodiazepine dosage	At 48 hours after study enrollment	Mean changes in Benzodiazepine doses
Bedside provider calls for dyspnea	At 48 hours after study enrollment	Mean changes in bedside provider calls for dyspnea

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States