Device arm for Shortness of Breath

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shortness of BreathPneumoCool - Device
Eligibility
18 - 110
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: From enrollment to hospital discharge or 30 days whichever happens earlier

Hour 48
Bedside provider calls for dyspnea
Benzodiazepine dosage
Bronchodilator dosage
Opoid dosage
Supplemental oxygen
Hour 8
Dyspnea
Borg Dyspnea scale ( (0 indicating no effort of breathing, 10 indicating maximal effort of breathing)
Visual analog scale (0 indicating no trouble breathing, 10 indicating severe shortness of breath)
visual analog scale
Day 30
External cooling devices
Day 60
Hospital length of stay
Need for Noninvasive positive pressure ventilation [NIPPV] or Invasive mechanical ventilation)
Day 60
ICU length of stay

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Device arm
1 of 2
Standard of Care arm
1 of 2

Active Control

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Device arm · Has Placebo Group · N/A

Standard of Care arm
Other
PlaceboComparator Group · 1 Intervention: Current supportive measures that are used in the hospital for standard of care · Intervention Types: Other
Device arm
Device
ActiveComparator Group · 1 Intervention: PneumoCool · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment to hospital discharge or 30 days whichever happens earlier

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
716 Previous Clinical Trials
464,460 Total Patients Enrolled
Sonal R Pannu, MDPrincipal InvestigatorOhio State University

Eligibility Criteria

Age 18 - 110 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are admitted to the hospital with a suspected cancer.