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

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.

Study Overview

• Status: Terminated
• Conditions: Abdominal Surgery
• Intervention / Treatment: Device: Conventional spirometer; Device: MIR Spirobank G; Device: ZEPHYRx®

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Conventional spirometer; Will be provided to participants
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.	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.
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)	Device: Conventional spirometer; Will be provided to participants
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Chet Hammill, M.D., MCR, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202105028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No