Digital Incentive Spirometry Adherence

Last updated: October 1, 2025
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

N/A

Condition

Thoracotomy

Open Heart Surgery

Cardiac Surgery

Treatment

Adherence to digital incentive spirometer in the postop period after major chest surgery.

Clinical Study ID

NCT06629454
ebebfaib
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Male or female, 18 years or older.

  4. Undergoes any anatomic lung resection surgery

  5. An incentive spirometer is expected to be ordered for the patient asstandard-of-care

  6. There is no restriction on active medications.

Exclusion

Exclusion Criteria:

There are no exclusions based on economic status, gender, race, or ethnicity. An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Vulnerable populations who in the opinion of the investigator are unable to giveInformed Consent for reasons of incapacity, immaturity, adverse personalcircumstances or lack of autonomy.

  2. History of prior non-compliance to prescribed therapy or presence or history ofsignificant psychiatric condition (e.g., drug or alcohol addiction, psychosis,schizophrenia), or cognitive issue which would in the opinion of the investigator,make it difficult for the patient to comply with the study procedures or follow theinvestigators instructions.

  3. Populations for whom in the opinion of the investigator, incentive spirometry isdeemed inappropriate due to medical condition or otherwise.

  4. Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensedmedical professionals on the clinical team will follow proper procedures indetermining if the individual is consenting. Proper procedures entail doing all ofthe following: giving a patient adequate information concerning the study, providingadequate opportunity for the patient to consider all options, responding to thepatient's questions, ensuring that the patient has comprehended this information,obtaining the patient's voluntary agreement to participate and, continuing toprovide information as the patient or situation requires. There will be ampleopportunity for the patient to ask questions. In the event that the patient is in avulnerable population and unable to provide consent, they will not be eligible toparticipate in the study and thus will not be screened. If the individual is notable to provide informed consent or if consent is not certain due to impairments orother factors, they will not be considered for study participation. In the eventthat the patient is in a vulnerable population and unable to provide consent, theywill not be eligible to participate in the study and thus will not be screened.

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Adherence to digital incentive spirometer in the postop period after major chest surgery.
Phase:
Study Start date:
December 27, 2024
Estimated Completion Date:
July 31, 2025

Study Description

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.

Connect with a study center

  • Penn Medicine Cherry Hill

    Cherry Hill, New Jersey 08003
    United States

    Site Not Available

  • Penn Medicine Cherry Hill

    Cherry Hill 4501198, New Jersey 5101760 08003
    United States

    Site Not Available

  • Penn Medicine Valley Forge

    Berwyn, Pennsylvania 19312
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Penn Medicine University City

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Thoracic Surgery Presbyterian

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Medicine Valley Forge

    Berwyn 5180102, Pennsylvania 6254927 19312
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Penn Medicine University City

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Penn Thoracic Surgery Presbyterian

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Perelman Center for Advanced Medicine

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

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