Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

Washington University School of Medicine2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Abdominal Surgery

Interventions

MIR Spirobank G

FDA-approved, Bluetooth digital spirometer

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.

Conventional spirometerDEVICE

Will be provided to participants

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: From baseline to day-of-surgery preoperative

Secondary Outcomes

Change in Forced Vital Capacity (FVC)

Time frame: From baseline to day-of-surgery preoperative

Change in Pulse Oximetry

Time frame: From baseline to day-of-surgery preoperative

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

Time frame: From day 1 to postoperative day 3

Change in Forced Vital Capacity (FVC)

Time frame: From day 1 to postoperative day 3

Change in Pulse Oximetry

Time frame: From day 1 to postoperative day 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.