Incentive Spirometry, Lung Resection, Patient Adherence, Pulmonary Function, Thoracic Surgery
Conditions
Keywords
Incentive spirometer, Patient adherence, Digital incentive spirometer
Brief 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.
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.
Interventions
DEVICEAdherence 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.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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? |
| 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: |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
31 patients enrolled. 30 patients completed per protocol.
Pre-assignment details
One participant was withdrawn from the study by clinician decision.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdraw by Clinician Decision | 1 |
Baseline characteristics
| Characteristic | Single Arm Proof of Concept Study of a Digital Incentive Spirometer |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 66.7 inches |
| Preoperative Incentive Spirometry Flow Rate Average flow rate | 259 milliliters per second |
| Preoperative Incentive Spirometry Flow Rate Maximum flow rate | 386 milliliters per second |
| Preoperative Incentive Spirometry Volume Average preoperative volume | 2066 milliliters |
| Preoperative Incentive Spirometry Volume Maximum preoperative volume | 2339 milliliters |
| Procedure Target Lobe Left Lower Lobe | 3 Participants |
| Procedure Target Lobe Left Upper Lobe | 5 Participants |
| Procedure Target Lobe More than one lobe | 3 Participants |
| Procedure Target Lobe Right Lower Lobe | 8 Participants |
| Procedure Target Lobe Right Middle Lobe | 1 Participants |
| Procedure Target Lobe Right Upper Lobe | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
| Weight | 177 pounds (lbs) |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Incentive Spirometry Adherence (Breath Attempts Per Day)
Number of inspiratory breath attempts performed with the digital IS per day.
Time frame: Till discharge or up to 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Incentive Spirometry Adherence (Breath Attempts Per Day) | 45 Breath attempts |
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.
Time frame: Till discharge or up to 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath) | 7.6 Hours |
Secondary
Blood Oxygen Saturation
Average postoperative SpO2 per patient. Mean is the mean across the patient cohort.
Time frame: Till discharge or up to 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Blood Oxygen Saturation | 96 percentage of oxygen saturation |
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.
Time frame: Till discharge or up to 7 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Flow Rate of Inspiratory Breaths Attempted From the Digital IS | Average flow rate | 186 Milliliters per second |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Flow Rate of Inspiratory Breaths Attempted From the Digital IS | Maximum flow rate | 357 Milliliters per second |
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.
Time frame: Till discharge or up to 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Pain Scores | 4 units on a scale from 0 to 10 |
Secondary
Volume of Inspiratory Breaths Attempted With the Digital IS
Inspiratory volume in milliliters measured from one inhalation from the device
Time frame: Till discharge or up to 7 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Volume of Inspiratory Breaths Attempted With the Digital IS | Average postoperative volume | 1314 milliliters |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Volume of Inspiratory Breaths Attempted With the Digital IS | Maximum postoperative volume | 2375 milliliters |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) | 79.0 percentage of predicted value |
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:
Time frame: On the day of patient discharge from the hospital, an average of 3 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Strongly Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Strongly Agree | 14 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Agree | 6 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Neutral | 1 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Disagree | 1 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Strongly Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Incomplete | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to know when to do my exercises with my device. | Not applicable | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Strongly Agree | 7 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Agree | 10 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Neutral | 5 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Strongly Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Incomplete | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I felt motivated to do my exercises. | Not applicable | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Strongly Agree | 14 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Agree | 10 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Neutral | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Strongly Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Incomplete | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | It was easy to click the button on my device to start an exercise when I wanted to. | Not applicable | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Strongly Agree | 9 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Agree | 8 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Neutral | 3 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Disagree | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Strongly Disagree | 1 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Incomplete | 1 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how the device gave spoken (audio) instructions for the exercises. | Not applicable | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Strongly Agree | 11 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Agree | 8 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Neutral | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Strongly Disagree | 1 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Incomplete | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked how my nurse/doctor could see my breathing exercise measurements. | Not applicable | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Strongly Agree | 6 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Agree | 5 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Neutral | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Incomplete | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I was able to set up the app easily. | Not applicable | 11 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Strongly Agree | 3 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Agree | 6 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Neutral | 3 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Strongly Disagree | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Incomplete | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Device Engagement | I liked the app features. | Not applicable | 10 Participants |
Other Pre-specified
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
Discharge Survey Question: How much of you exercises do you think you completed?
Time frame: On the day of patient discharge from the hospital, an average of 3 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | 0-20%, Close to none | 0 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | 21-40%, A few of them | 2 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | 41-60%, Around half | 7 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | 61-80%, More than half | 9 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | 81-100%, Almost all | 6 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Exercise Completion Self-Reported Adherence | Incomplete | 0 Participants |
Other Pre-specified
Discharge Survey Responses - Previous Incentive Spirometry
Have you used an incentive spirometer prior to this hospital stay?
Time frame: On the day of patient discharge from the hospital, an average of 3 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Previous Incentive Spirometry | YES | 7 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Previous Incentive Spirometry | NO | 12 Participants |
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Discharge Survey Responses - Previous Incentive Spirometry | Incomplete | 5 Participants |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Expiratory Reserve Volume (ERV) | 95.5 percentage of predicted value |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Forced Expiratory Flow (FEF25-75) | 93.9 percentage of predicted value |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Forced Expiratory Volume in 1 Second (FEV-1) | 90.6 percentage of predicted value |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Forced Vital Capacity (FVC) | 94.4 percentage of predicted value |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Residual Volume (RV) | 108 percentage of predicted value |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Thoracic Gas Volume (TGV) | 99.9 percentage of predicted value |
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.
Time frame: up to 2 weeks before the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm Proof of Concept Study of a Digital Incentive Spirometer | Total Lung Capacity (TLC) | 94.1 percentage of predicted value |
Other Pre-specified
Vital Capacity (VC)
Preoperative vital capacity of the lungs.
Time frame: up to 2 weeks before the surgery
Population: This metric was not collected as part of standard of care pulmonary function testing.