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Clinical Trials/NCT04887922
NCT04887922
Terminated
Not Applicable

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

Washington University School of Medicine1 site in 1 country2 target enrollmentMay 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Surgery
Sponsor
Washington University School of Medicine
Enrollment
2
Locations
1
Primary Endpoint
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2022
End Date
December 27, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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 Pulse Oximetry(From day 1 to postoperative day 3)
  • Change in Forced Vital Capacity (FVC)(From day 1 to postoperative day 3)
  • Change in Forced Expiratory Volume in One Second Parameter (FEV1)(From day 1 to postoperative day 3)

Study Sites (1)

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