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Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04887922
Recruitment Status : Not yet recruiting
First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Abdominal Surgery Device: MIR Spirobank G Device: ZEPHYRx® Device: Conventional spirometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
  • Prior to surgery, participants will be randomized into three groups: (1) control group with no IS, (2) standard IS, and (3) digital IS + text message.
  • Following surgery, patients will be re-randomized into two groups: (1) standard IS, and (2) digital IS + text message.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
Estimated Study Start Date : June 30, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Arm Intervention/treatment
No Intervention: Pre-Surgery: No Incentive Spirometry (IS)
-Will not receive a incentive spirometer prior to surgery
Experimental: Pre-Surgery: Standard Incentive Spirometry (IS)
  • Will receive a conventional spirometer prior to surgery
  • Will be asked to perform spirometry 10 times per hour, every hour while awake, every day for at least 7 days prior to surgery.
Device: Conventional spirometer
Will be provided to participants

Experimental: 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.
Device: MIR Spirobank G
FDA-approved, Bluetooth digital spirometer

Device: 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.

Active Comparator: 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)
Device: Conventional spirometer
Will be provided to participants

Experimental: 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.
Device: MIR Spirobank G
FDA-approved, Bluetooth digital spirometer

Device: 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.




Primary Outcome Measures :
  1. Change in FEV1 [ Time Frame: From baseline to day-of-surgery preoperative ]

Secondary Outcome Measures :
  1. Change in FVC [ Time Frame: From baseline to day-of-surgery preoperative ]
  2. Change in pulse oximetry [ Time Frame: From baseline to day-of-surgery preoperative ]
  3. Change in FEV1 [ Time Frame: From day 1 to postoperative day 3 ]
  4. Change in FVC [ Time Frame: From day 1 to postoperative day 3 ]
  5. Change in pulse oximetry [ Time Frame: From day 1 to postoperative day 3 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887922


Contacts
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Contact: Chet Hammill, M.D., MCR 314-273-1809 hammillc@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Chet Hammill, M.D., MCR    314-273-1809    hammillc@wustl.edu   
Principal Investigator: Chet Hammill, M.D., MCR         
Sub-Investigator: Dominic Sanford, M.D., MPH         
Sub-Investigator: William Hawkins, M.D., FACS         
Sub-Investigator: Steven Strasberg, M.D., FACS         
Sub-Investigator: Ryan Fields, M.D., FACS         
Sub-Investigator: Jorge Zarate Rodriguez, M.D.         
Sub-Investigator: Esther Lu, M.S., Ph.D.         
Sub-Investigator: Gregory Williams, M.A.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Chet Hammill, M.D., MCR Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04887922    
Other Study ID Numbers: 202105028
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No