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Digital Incentive Spirometer for Assessing Incentive Spirometry Adherence
This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.
Incentive spirometry is frequently prescribed as a standard-of-care for patients post-surgery to reduce the risk of developing postoperative pulmonary complications associated with atelectasis. An incentive spirometer (IS) is a mechanical breathing device that assists with pulmonary rehabilitation through improving lung expansion by encouraging deep breathing. While performing incentive spirometry exercises is effective at lowering atelectasis severity, ventilation time, and pulmonary complication rates, patient adherence to performing exercises is very poor. Medical staff, due to time constraints, often cannot supervise all of their patients' entire incentive spirometry regimens (usually every 10-15 min during wakeful hours), contributing to low adherence and incorrect exercise completion. This is compounded by current incentive spirometers lacking a method for accurately collecting patient exercise and adherence data. The present study seeks to evaluate the effect of a digital IS that provides instruction signals and exercise reminders on patients' incentive spirometry adherence. This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use. The objective of this study is to evaluate the effect of a digital IS that provides gentle auditory and haptic reminders and exercise guidance on patient adherence to incentive spirometry. Secondarily, this study will evaluate metrics relating to lung function to assess post-surgery lung recovery in patients using the digital IS.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Penn Medicine Cherry Hill
Cherry Hill, New Jersey, United States
Penn Medicine Valley Forge
Berwyn, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Medicine University City
Philadelphia, Pennsylvania, United States
Penn Thoracic Surgery Presbyterian
Philadelphia, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Start Date
December 27, 2024
Primary Completion Date
July 31, 2025
Completion Date
July 31, 2025
Last Updated
October 20, 2025
31
ACTUAL participants
Adherence to digital incentive spirometer in the postop period after major chest surgery.
DEVICE
Lead Sponsor
University of Pennsylvania
NCT06972784
NCT06404164
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05515809