Digital Incentive Spirometry Adherence

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery; Pulmonary Function; Lung Resection; Patient Adherence; Incentive Spirometry
• Intervention / Treatment: Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Penn Medicine Cherry Hill
  • Pennsylvania
    • Berwyn, Pennsylvania, United States, 19312
      • Penn Medicine Valley Forge
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center For Advanced Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine University City
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Thoracic Surgery Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration 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 as standard-of-care
6. There is no restriction on active medications.

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 give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
2. History of prior non-compliance to prescribed therapy or presence or history of significant 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 the investigators instructions.
3. Populations for whom in the opinion of the investigator, incentive spirometry is deemed inappropriate due to medical condition or otherwise.
4. Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensed medical professionals on the clinical team will follow proper procedures in determining if the individual is consenting. Proper procedures entail doing all of the following: giving a patient adequate information concerning the study, providing adequate opportunity for the patient to consider all options, responding to the patient's questions, ensuring that the patient has comprehended this information, obtaining the patient's voluntary agreement to participate and, continuing to provide information as the patient or situation requires. There will be ample opportunity for the patient to ask questions. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened. If the individual is not able to provide informed consent or if consent is not certain due to impairments or other factors, they will not be considered for study participation. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm proof of concept study of a digital incentive spirometer; 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.

Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.; Major chest surgery can lead to respiratory compromise and traditional breathing exercises are not supervised or monitored. The primary objective of this study is to evaluate the effect of a multifeatured digital IS and integrated phone app on patient adherence to incentive spirometry. Together the device and app will include the following functions: an auditory and haptic reminder cue, visual and auditory cues to guide exercise completion, exercise gamification, and data tracking and visualization features.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incentive Spirometry Adherence (Breath Attempts Per Day)	Number of inspiratory breath attempts performed with the digital IS per day.	Till discharge or up to 7 days
Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)	Number of hours in which at least one inspiratory breath was attempted using the digital IS per day.	Till discharge or up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of Inspiratory Breaths Attempted With the Digital IS	Inspiratory volume in milliliters measured from one inhalation from the device	Till discharge or up to 7 days
Blood Oxygen Saturation	Average postoperative SpO2 per patient. Mean is the mean across the patient cohort.	Till discharge or up to 7 days
Pain Scores	Postoperative pain scores will be reported on a scale from 0 (no pain) to 10 (unbearable pain). These are then averaged per patient. Mean and range is reported for the entirely of the patient cohort.	Till discharge or up to 7 days
Flow Rate of Inspiratory Breaths Attempted From the Digital IS	Flow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device.	Till discharge or up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)	Preoperative diffusing capacity of the lung for carbon monoxide to move from air sacs into the bloodstream as a percent of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Forced Expiratory Volume in 1 Second (FEV-1)	Preoperative forced expiration volume in 1 second as a percentage of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Forced Vital Capacity (FVC)	Preoperative forced vital capacity of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Vital Capacity (VC)	Preoperative vital capacity of the lungs.	up to 2 weeks before the surgery
Residual Volume (RV)	Preoperative residual volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Total Lung Capacity (TLC)	Preoperative total lung capacity as a percentage of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Forced Expiratory Flow (FEF25-75)	Forced expiratory flow rate between 25% and 75% of the forced vital capacity, pre-bronchodilator, as a percentage of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Thoracic Gas Volume (TGV)	Total gas volume within the chest cavity when the airway is temporarily blocked as a percent of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Expiratory Reserve Volume (ERV)	Expiratory reserve volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.	up to 2 weeks before the surgery
Discharge Survey Responses - Device Engagement	Device engagement survey responses. Patients are instructed on the paper survey to "Circle how much you agree or disagree with the following statements:"	On the day of patient discharge from the hospital, an average of 3 days
Discharge Survey Responses - Previous Incentive Spirometry	Have you used an incentive spirometer prior to this hospital stay?	On the day of patient discharge from the hospital, an average of 3 days
Discharge Survey Responses - Exercise Completion Self-Reported Adherence	Discharge Survey Question: How much of you exercises do you think you completed?	On the day of patient discharge from the hospital, an average of 3 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Doraid Jarrar, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Patient adherence; Incentive spirometer; Digital incentive spirometer
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Compliance
• Other Study ID Numbers: ebebfaib

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No