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

Dyspnea Clinical Trial

— BREATHE-easy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416437
• Other study ID #: 2021H0334
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: sonal pannu
• Phone: 6142937708
• Email: sonal.pannu[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea

Intervention

Device:
• PneumoCool
Device to channel medical air to the patient to alleviate 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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)	Mean Change visual analog scale	At 8 hours after enrollment
Secondary	Supplemental oxygen	change of supplemental oxygen	At 48 hours after study enrollment
Secondary	External cooling devices	Duration of external cooling devices (hours)	From enrollment to hospital discharge or 30 days whichever happens earlier
Secondary	Bronchodilator dosage	Mean changes in Bronchodilator doses	At 48 hours after study enrollment
Secondary	Benzodiazepine dosage	Mean changes in Benzodiazepine doses	At 48 hours after study enrollment
Secondary	Opoid dosage	Mean changes in Opoid doses	At 48 hours after study enrollment
Secondary	Bedside provider calls for dyspnea	Mean changes in bedside provider calls for dyspnea	At 48 hours after study enrollment
Secondary	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
Secondary	Hospital length of stay	Note duration of hospitalization	Upto hospital discharge or death which every happens earlier upto 60 day after enrollment
Secondary	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