Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

NCT04887922 | Terminated Results FDA Device

• 1 other identifier: 202105028
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Forced Expiratory Volume in One Second Parameter (FEV1)

  From baseline to day-of-surgery preoperative

Secondary Outcomes (5)

• 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

Study Arms (5)

Pre-Surgery: No Incentive Spirometry (IS)

NO INTERVENTION

-Will not receive a incentive spirometer prior to surgery

Pre-Surgery: Standard Incentive Spirometry (IS)

EXPERIMENTAL

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

Device: Conventional spirometer

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

EXPERIMENTAL

* 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; Device: ZEPHYRx®

Post-Surgery: Standard Incentive Spirometry (IS)

ACTIVE COMPARATOR

* 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

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

EXPERIMENTAL

* 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; Device: ZEPHYRx®

Interventions

MIR Spirobank G DEVICE

FDA-approved, Bluetooth digital spirometer

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

ZEPHYRx® DEVICE

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.

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

Conventional spirometer DEVICE

Will be provided to participants

Post-Surgery: Standard Incentive Spirometry (IS); Pre-Surgery: Standard Incentive Spirometry (IS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years of age
• No access to a smartphone

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Results Point of Contact

• Title: Chet Hammill, M.D., MCR
• Organization: Washington University School of Medicine

hamillc@wustl.edu

314-273-1809

Study Officials

• Chet Hammill, M.D., MCR

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Prior to surgery, participants will be randomized into three groups: (1) control group with no IS, (2) standard IS, and (3) digital IS + text message. * Following surgery, patients will be re-randomized into two groups: (1) standard IS, and (2) digital IS + text message.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: May 3, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)