Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

The Washington University

Status: Terminated

Conditions: Abdominal Surgery

Treatments: Device: MIR Spirobank G; Device: ZEPHYRx®; Device: Conventional spirometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04887922

202105028

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

2 participants in 5 patient groups

Pre-Surgery: No Incentive Spirometry (IS)

No Intervention group

Description:

-Will not receive a incentive spirometer prior to surgery

Pre-Surgery: Standard Incentive Spirometry (IS)

Experimental group

Description:

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

Treatment:

Device: Conventional spirometer

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

Experimental group

Description:

* 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.

Treatment:

Device: ZEPHYRx®

Device: MIR Spirobank G

Post-Surgery: Standard Incentive Spirometry (IS)

Active Comparator group

Description:

* 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)

Treatment:

Device: Conventional spirometer

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

Experimental group

Description:

* 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.

Treatment:

Device: ZEPHYRx®

Device: MIR Spirobank G