Clinical trial NCT05416437: Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
Official title: Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dyspnea
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
timeFrame: At 8 hours after enrollment
Secondary outcomes:
measure: Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)
timeFrame: At 8 hours after enrollment
measure: Supplemental oxygen
timeFrame: At 48 hours after study enrollment
measure: External cooling devices
timeFrame: From enrollment to hospital discharge or 30 days whichever happens earlier
measure: Bronchodilator dosage
timeFrame: At 48 hours after study enrollment
measure: Benzodiazepine dosage
timeFrame: At 48 hours after study enrollment
measure: Opoid dosage
timeFrame: At 48 hours after study enrollment
measure: Bedside provider calls for dyspnea
timeFrame: At 48 hours after study enrollment
measure: Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation)
timeFrame: Upto hospital discharge or death which every happens earlier upto 60 day after enrollment
measure: Hospital length of stay
timeFrame: Upto hospital discharge or death which every happens earlier upto 60 day after enrollment
measure: ICU length of stay
timeFrame: Upto transfer from ICU or death which every happens earlier upto 60 day after enrollment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Sonal R Pannu, MD
role: PRINCIPAL_INVESTIGATOR
References: