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

Status: Terminated

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

United States

Missouri

Washington University School of Medicine

Saint Louis

Time Frame

Start Date: 2022-05-03

Completion Date: 2022-12-27

Participants

Target number of participants: 2

Treatments

No_intervention: Pre-Surgery: No Incentive Spirometry (IS)

-Will not receive a incentive spirometer prior to surgery

Experimental: Pre-Surgery: Standard Incentive Spirometry (IS)

* Will receive a conventional spirometer prior to surgery~* Will be asked to perform spirometry 30 times per day.

Experimental: Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message

* 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.

Active_comparator: Post-Surgery: Standard Incentive Spirometry (IS)

* 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)

Experimental: Post-Surgery: Digital Incentive Spirometry (IS) + Text Message

* 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.

Authors

Gregory Williams, Ryan Fields, Dominic Sanford, Chet Hammill, Steven Strasberg, William Hawkins

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

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