Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

Not Applicable

Terminated

Conditions: Abdominal Surgery

Interventions: Device: Conventional spirometer
Device: MIR Spirobank G
Device: ZEPHYRx®

Registration Number: NCT04887922

Lead Sponsor: Washington University School of Medicine

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pre-Surgery: Standard Incentive Spirometry (IS)	Conventional spirometer	* Will receive a conventional spirometer prior to surgery * Will be asked to perform spirometry 30 times per day.
Post-Surgery: Standard Incentive Spirometry (IS)	Conventional spirometer	* 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)
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message	MIR Spirobank G	* 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.
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message	MIR Spirobank G	* 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.
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message	ZEPHYRx®	* 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.
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message	ZEPHYRx®	* 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.

Primary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in One Second Parameter (FEV1)	From baseline to day-of-surgery preoperative

Secondary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in One Second Parameter (FEV1)	From day 1 to postoperative day 3
Change in Pulse Oximetry	From day 1 to postoperative day 3
Change in Forced Vital Capacity (FVC)	From day 1 to postoperative day 3