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NCT Number: NCT05416437

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PneumoCool

Device

Device to channel medical air to the patient to alleviate dyspnea

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

Primary outcomes

  1. Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)

    Time frame: 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 outcomes

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

    Time frame: At 8 hours after enrollment

    Mean Change visual analog scale

  2. Supplemental oxygen

    Time frame: At 48 hours after study enrollment

    change of supplemental oxygen

  3. External cooling devices

    Time frame: From enrollment to hospital discharge or 30 days whichever happens earlier

    Duration of external cooling devices (hours)

  4. Bronchodilator dosage

    Time frame: At 48 hours after study enrollment

    Mean changes in Bronchodilator doses

  5. Benzodiazepine dosage

    Time frame: At 48 hours after study enrollment

    Mean changes in Benzodiazepine doses

  6. Opoid dosage

    Time frame: At 48 hours after study enrollment

    Mean changes in Opoid doses

  7. Bedside provider calls for dyspnea

    Time frame: At 48 hours after study enrollment

    Mean changes in bedside provider calls for dyspnea

  8. Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation)

    Time frame: 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

  9. Hospital length of stay

    Time frame: Upto hospital discharge or death which every happens earlier upto 60 day after enrollment

    Note duration of hospitalization

  10. ICU length of stay

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: BREATHE-easy

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 13, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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