NCT04887922TerminatedNot 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 enrollmentStarted: May 3, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pre-Surgery: No Incentive Spirometry (IS)
No Intervention
-Will not receive a incentive spirometer prior to surgery
Pre-Surgery: Standard Incentive Spirometry (IS)
Experimental
- Will receive a conventional spirometer prior to surgery
- Will be asked to perform spirometry 30 times per day.
Intervention: Conventional spirometer (Device)
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- 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.
Intervention: MIR Spirobank G (Device)
Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- 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.
Intervention: ZEPHYRx® (Device)
Post-Surgery: Standard Incentive Spirometry (IS)
Active Comparator
- 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)
Intervention: Conventional spirometer (Device)
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- 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.
Intervention: MIR Spirobank G (Device)
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message
Experimental
- 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.
Intervention: ZEPHYRx® (Device)
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)
- Change in Forced Vital Capacity (FVC)(From baseline to day-of-surgery preoperative)
- Change in Pulse Oximetry(From baseline to day-of-surgery preoperative)
Investigators
Study Sites (1)
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