NCT04887922

Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Surgery

Interventions

Type	Name	Description
DEVICE	MIR Spirobank G	FDA-approved, Bluetooth digital spirometer
DEVICE	ZEPHYRx®	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.
DEVICE	Conventional spirometer	Will be provided to participants

Timeline

• Start date: 2022-05-03
• Primary completion: 2022-12-27
• Completion: 2022-12-27
• First posted: 2021-05-14
• Last updated: 2023-05-17
• Results posted: 2023-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study