Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
NCT ID: NCT04887922
Last Updated: 2023-05-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2022-05-03
2022-12-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
* Following surgery, patients will be re-randomized into two groups: (1) standard IS, and (2) digital IS + text message.
SUPPORTIVE_CARE
NONE
Study Groups
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Pre-Surgery: No Incentive Spirometry (IS)
-Will not receive a incentive spirometer prior to surgery
No interventions assigned to this group
Pre-Surgery: Standard Incentive Spirometry (IS)
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
Conventional spirometer
Will be provided to participants
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message
* 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.
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.
Post-Surgery: Standard Incentive Spirometry (IS)
* 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)
Conventional spirometer
Will be provided to participants
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message
* 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.
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* No access to a smartphone
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Chet Hammill, M.D., MCR
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202105028
Identifier Type: -
Identifier Source: org_study_id
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