Status:
UNKNOWN
A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry
Lead Sponsor:
My Music Machines Inc.
Collaborating Sponsors:
University of Rochester
Conditions:
Thoracic Surgery
Respiratory Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The primary aim of this randomized control trial is to analyze by direct comparison the ZEPHYRx Respiratory Therapy (RT) system and the FDA approved standard of care (SOC) incentive spirometer (IS), u...
Detailed Description
Lobectomy and wedge resection patients at University of Rochester Medical Center meeting the eligibility criteria will be screened and consented by members of the research team prior to surgery at the...
Eligibility Criteria
Inclusion
- Adult Patients ages 18+ undergoing thoracic lobectomy surgery or wedge resection for tumor/nodule excisionat the University of Rochester Medical Center.
Exclusion
- Patients under the age of 18
- Patients with diminished physical or mental capacity that make them incapable of operating a standard spirometer device
- Patients with visual or hearing impairments that make it difficult to understand verbal or written instructions
- Patients who are not able to read the language the ZEPHYRx software is available in (currently available only in English)
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04429009
Start Date
September 1 2021
End Date
September 30 2023
Last Update
August 25 2022
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642