Digital Incentive Spirometry Adherence

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.

• Adherence to digital incentive spirometer in the postop period after major chest surgery. (Device): 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.

Primary outcomes

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

Secondary outcomes

• Volume of Inspiratory Breaths Attempted With the Digital IS [Till discharge or up to 7 days]: Inspiratory volume in milliliters measured from one inhalation from the device
• Blood Oxygen Saturation [Till discharge or up to 7 days]: Average postoperative SpO2 per patient. Mean is the mean across the patient cohort.
• Pain Scores [Till discharge or up to 7 days]: 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.
• Flow Rate of Inspiratory Breaths Attempted From the Digital IS [Till discharge or up to 7 days]: Flow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device.

Other outcomes

• Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [up to 2 weeks before the surgery]: 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.
• Forced Expiratory Volume in 1 Second (FEV-1) [up to 2 weeks before the surgery]: Preoperative forced expiration volume in 1 second as a percentage of predicted value based on the person's age, sex, height, and other factors.
• Forced Vital Capacity (FVC) [up to 2 weeks before the surgery]: Preoperative forced vital capacity of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
• Vital Capacity (VC) [up to 2 weeks before the surgery]: Preoperative vital capacity of the lungs.
• Residual Volume (RV) [up to 2 weeks before the surgery]: Preoperative residual volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
• Total Lung Capacity (TLC) [up to 2 weeks before the surgery]: Preoperative total lung capacity as a percentage of predicted value based on the person's age, sex, height, and other factors.
• Forced Expiratory Flow (FEF25-75) [up to 2 weeks before the surgery]: 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.
• Thoracic Gas Volume (TGV) [up to 2 weeks before the surgery]: 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.
• Expiratory Reserve Volume (ERV) [up to 2 weeks before the surgery]: Expiratory reserve volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
• Discharge Survey Responses - Device Engagement [On the day of patient discharge from the hospital, an average of 3 days]: Device engagement survey responses. Patients are instructed on the paper survey to "Circle how much you agree or disagree with the following statements:"
• Discharge Survey Responses - Previous Incentive Spirometry [On the day of patient discharge from the hospital, an average of 3 days]: Have you used an incentive spirometer prior to this hospital stay?
• Discharge Survey Responses - Exercise Completion Self-Reported Adherence [On the day of patient discharge from the hospital, an average of 3 days]: Discharge Survey Question: How much of you exercises do you think you completed?

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Incentive Spirometry Adherence (Breath Attempts Per Day) (Primary), Mean, Breath attempts: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 45 (23 to 59)
• Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath) (Primary), Mean, Hours: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 7.6 (5.75 to 10)
• Volume of Inspiratory Breaths Attempted With the Digital IS (Secondary), Mean, milliliters: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 1314 (403 to 2517)
• Blood Oxygen Saturation (Secondary), Mean, percentage of oxygen saturation: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 96 (93 to 98)
• Pain Scores (Secondary), Mean, units on a scale from 0 to 10: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 4 (0 to 7)
• Flow Rate of Inspiratory Breaths Attempted From the Digital IS (Secondary), Mean, Milliliters per second: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 186 (132 to 288)
• Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 79.0 (26.1 to 124)
• Forced Expiratory Volume in 1 Second (FEV-1) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 90.6 (21.5 to 129.3)
• Forced Vital Capacity (FVC) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 94.4 (66.3 to 135.5)
• Vital Capacity (VC) (Other pre specified)
• Residual Volume (RV) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 108 (75.3 to 203.6)
• Total Lung Capacity (TLC) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 94.1 (74.3 to 123.0)
• Forced Expiratory Flow (FEF25-75) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 93.9 (8.2 to 189.3)
• Thoracic Gas Volume (TGV) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 99.9 (74.7 to 155)
• Expiratory Reserve Volume (ERV) (Other pre specified), Mean, percentage of predicted value: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 95.5 (29.8 to 166.9)
• Discharge Survey Responses - Device Engagement (Other pre specified), Count of participants, Participants: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 14
• Discharge Survey Responses - Previous Incentive Spirometry (Other pre specified), Count of participants, Participants: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 7
• Discharge Survey Responses - Exercise Completion Self-Reported Adherence (Other pre specified), Count of participants, Participants: Single Arm Proof of Concept Study of a Digital Incentive Spirometer 0

Adverse events

Time frame: From Enrollment Until 4 Months After Discharge, up to 18 weeks

Limitations and caveats: This was a single-arm, open-label study.

• Study Protocol and Statistical Analysis Plan (PDF, 2024-08-19)
• Informed Consent Form (PDF, 2024-11-01)

• Doraid Jarrar, MD, Principal investigator, University of Pennsylvania