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Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

NCT04887922 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-05-17

Study results available
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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

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Chet Hammill, M.D., MCR · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2022-12-27
Completion
2022-12-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887922 on ClinicalTrials.gov