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NCT04887922 Clinical Trial

Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

Abdominal Surgery Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04887922
Other study ID # 202105028
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 3, 2022
Est. completion date December 27, 2022

Study information
Verified date April 2023
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date December 27, 2022
Est. primary completion date December 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MIR Spirobank G
FDA-approved, Bluetooth digital spirometer
• 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.
• Conventional spirometer
Will be provided to participants

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Forced Expiratory Volume in One Second Parameter (FEV1) From baseline to day-of-surgery preoperative
Secondary Change in Forced Vital Capacity (FVC) From baseline to day-of-surgery preoperative
Secondary Change in Pulse Oximetry From baseline to day-of-surgery preoperative
Secondary Change in Forced Expiratory Volume in One Second Parameter (FEV1) From day 1 to postoperative day 3
Secondary Change in Forced Vital Capacity (FVC) From day 1 to postoperative day 3
Secondary Change in Pulse Oximetry From day 1 to postoperative day 3
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