Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

Study Overview
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Brief Summary
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The goal of this study is to determine the efficacy of incentive spirometry (IS) to improve pulmonary function in the preoperative and postoperative surgical setting. The investigators hypothesize that IS will improve pulmonary function for patients undergoing major abdominal surgery when controlling for protocol compliance. Additionally, the investigators hypothesize that a digital IS device enabled with a text message-based mobile health intervention will improve pulmonary pre-habilitation and rehabilitation, as well as postoperative compliance with the IS device.

Official Title
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The Effect of Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

Conditions
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Abdominal Surgery

Intervention / Treatment
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* Device: MIR Spirobank G
* Device: ZEPHYRx®
* Device: Conventional spirometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo major abdominal surgery with expected postoperative length of stay of 48 hours or more. Access to a smartphone. At least 18 years of age. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Younger than 18 years of age No access to a smartphone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prior to surgery, participants will be randomized into three groups: (1) control group with no IS, (2) standard IS, and (3) digital IS + text message. Following surgery, patients will be re-randomized into two groups: (1) standard IS, and (2) digital IS + text message.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Surgery: No Incentive Spirometry (IS)<br>-Will not receive a incentive spirometer prior to surgery | |
| Experimental: Pre-Surgery: Standard Incentive Spirometry (IS)<br>Will receive a conventional spirometer prior to surgery Will be asked to perform spirometry 30 times per day. | Device: Conventional spirometer<br>* Will be provided to participants<br>|
| Experimental: Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message<br>Will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results. Will be asked to perform spirometry 10 times per hour, every hour while awake, every day for at least 7 days prior to surgery. Absence of spirometry for 24 hours will trigger a text message reminder to encourage compliance with IS. | Device: MIR Spirobank G<br>* FDA-approved, Bluetooth digital spirometer<br>Device: ZEPHYRx®<br>* ZEPHYRx® has developed a 1) digital Bluetooth-enabled IS that allows for the continuous and objective remote monitoring of patient compliance with pre- and postoperative IS via a smartphone app and online provider dashboard.<br>|
| Active Comparator: Post-Surgery: Standard Incentive Spirometry (IS)<br>After surgery, the participants will receive a conventional spirometer. Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3 The conventional spirometer will be equipped with an accelerometer that will allow the research team to determine whether the spirometer moves throughout the patients' postoperative stay (as a proxy for IS use) | Device: Conventional spirometer<br>* Will be provided to participants<br>|
| Experimental: Post-Surgery: Digital Incentive Spirometry (IS) + Text Message<br>After surgery, the participants will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results. Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3 Will receive text reminders to perform spirometry if they do not perform spirometry in a 24-hour period. | Device: MIR Spirobank G<br>* FDA-approved, Bluetooth digital spirometer<br>Device: ZEPHYRx®<br>* ZEPHYRx® has developed a 1) digital Bluetooth-enabled IS that allows for the continuous and objective remote monitoring of patient compliance with pre- and postoperative IS via a smartphone app and online provider dashboard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in One Second Parameter (FEV1) |  | From baseline to day-of-surgery preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Vital Capacity (FVC) |  | From baseline to day-of-surgery preoperative | 
| Change in Pulse Oximetry |  | From baseline to day-of-surgery preoperative | 
| Change in Forced Expiratory Volume in One Second Parameter (FEV1) |  | From day 1 to postoperative day 3 | 
| Change in Forced Vital Capacity (FVC) |  | From day 1 to postoperative day 3 | 
| Change in Pulse Oximetry |  | From day 1 to postoperative day 3 |