| Primary | Incentive Spirometry Adherence (Breath Attempts Per Day) | Number of inspiratory breath attempts performed with the digital IS per day. | | Posted | | Mean | Inter-Quartile Range | Breath attempts | | Till discharge or up to 7 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | 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. | | Posted | | Mean | Inter-Quartile Range | Hours | | Till discharge or up to 7 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Volume of Inspiratory Breaths Attempted With the Digital IS | Inspiratory volume in milliliters measured from one inhalation from the device | | Posted | | Mean | Full Range | milliliters | | Till discharge or up to 7 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Blood Oxygen Saturation | Average postoperative SpO2 per patient. Mean is the mean across the patient cohort. | | Posted | | Mean | Full Range | percentage of oxygen saturation | | Till discharge or up to 7 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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. | | Posted | | Mean | Full Range | units on a scale from 0 to 10 | | Till discharge or up to 7 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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. | | Posted | | Mean | Full Range | Milliliters per second | | Till discharge or up to 7 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | Vital Capacity (VC) | Preoperative vital capacity of the lungs. | This metric was not collected as part of standard of care pulmonary function testing. | Posted | | | | | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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. | | Posted | | Mean | Full Range | percentage of predicted value | | up to 2 weeks before the surgery | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | 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:" | | Posted | | Count of Participants | | Participants | | On the day of patient discharge from the hospital, an average of 3 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | Discharge Survey Responses - Previous Incentive Spirometry | Have you used an incentive spirometer prior to this hospital stay? | | Posted | | Count of Participants | | Participants | | On the day of patient discharge from the hospital, an average of 3 days | | | | ID | Title | Description |
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| OG000 | 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. |
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| Other Pre-specified | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | Discharge Survey Question: How much of you exercises do you think you completed? | | Posted | | Count of Participants | | Participants | | On the day of patient discharge from the hospital, an average of 3 days | | | | ID | Title | Description |
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| OG000 | 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. |
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