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Medical Device

PneumoCool Device for Shortness of Breath (BREATHE-easy Trial)

N/A
Recruiting
Led By Sonal R Pannu, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or more
Admitted to University hospital, ROSS or James Cancer Hospital with expected length of stay > 24 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours after study enrollment
Awards & highlights

BREATHE-easy Trial Summary

This trial is testing a new device to see if it can help people who are short of breath. The device is portable and uses medical-grade air.

Who is the study for?
This trial is for adults over 18 who are hospitalized with expected stays longer than a day and experiencing significant shortness of breath. It's not suitable for patients with delirium, dementia, brain injuries that prevent consent or device use, those on continuous mechanical ventilation, or prisoners.Check my eligibility
What is being tested?
The BREATHE-easy trial is testing the PneumoCool device against standard hospital care to see if it better relieves shortness of breath in patients. Participants will be randomly assigned to either receive this new bladeless air device or continue with usual supportive measures.See study design
What are the potential side effects?
Since the PneumoCool device uses medical-grade air to alleviate breathlessness without medications, side effects may be minimal compared to drug interventions but could include discomfort from using the device.

BREATHE-easy Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am admitted to the specified hospital and will stay for more than a day.
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I often feel short of breath.

BREATHE-easy Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 hours after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 hours after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
Secondary outcome measures
Bedside provider calls for dyspnea
Benzodiazepine dosage
Bronchodilator dosage
+7 more

BREATHE-easy Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Device armActive Control1 Intervention
The patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea
Group II: Standard of Care armPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,664 Total Patients Enrolled
Sonal R Pannu, MDPrincipal InvestigatorOhio State University

Media Library

PneumoCool (Medical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05416437 — N/A
Shortness of Breath Research Study Groups: Device arm, Standard of Care arm
Shortness of Breath Clinical Trial 2023: PneumoCool Highlights & Side Effects. Trial Name: NCT05416437 — N/A
PneumoCool (Medical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416437 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals accepted into this experimental program?

"According to the study's prerequisites, only individuals aged between 18 and 110 are eligible for enrollment. There are also 4 clinical trials available to those younger than 18 while 40 studies can be accessed by seniors over 65 years of age."

Answered by AI

Who qualifies for enrollment in this research endeavor?

"This medical research seeks 80 participants experiencing dyspnea and aged 18 or above. Essential requirements for inclusion are as follows: A score of greater than 3 on the Borg Scale, admission to University Hospital, ROSS or James Cancer Hospital with an expected duration of hospital stay exceeding 24 hours."

Answered by AI

Are there any opportunities to join this clinical trial at present?

"According to the clinicaltrials.gov database, recruitment for this trial is currently underway and has been since June 15th 2022. The posting was most recently revised on August 30th of that same year."

Answered by AI

What fundamental goals are being sought in this medical experiment?

"The primary endpoint of this clinical trial, assessed 8 hours after enrolment, is the Borg Dyspnea scale (with 0 indicating no effort to breathe and 10 representing maximal exertion). Secondary endpoints include shifts in opoid and benzodiazepine dosage as well as changes in Visual Analogue Scale scores (0 being no difficulty breathing, 10 signifying extreme breathlessness)."

Answered by AI

What is the overall count of participants taking part in this investigation?

"Affirmative. According to records on clinicaltrials.gov, the medical examination was first advertised on June 15th 2022 and is actively recruiting patients. 80 individuals will be required for this experiment which takes place in a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience
Sonal Pannu 2022. "Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05416437.
~28 spots leftby Apr 2025
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