Abdominal SurgeryNCT04887922
Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
A study testing MIR Spirobank G, ZEPHYRx® and Conventional spirometer in people with Abdominal Surgery, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- MIR Spirobank G, ZEPHYRx® and Conventional spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2022to 27 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Younger than 18 years of age
- No access to a smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Effect of Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
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.
- Conditions
- Abdominal Surgery
- Being tested
- MIR Spirobank G, ZEPHYRx®, Conventional spirometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIR Spirobank GDevice
FDA-approved, Bluetooth digital spirometer
ZEPHYRx®Device
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 spirometerDevice
Will be provided to participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Conventional spirometer |
| 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. Receives: Device: MIR Spirobank G; Device: ZEPHYRx® |
| 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) Receives: Device: Conventional spirometer |
| 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. Receives: Device: MIR Spirobank G; Device: ZEPHYRx® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Measured: From baseline to day-of-surgery preoperative
Secondary outcomes (5)
Change in Forced Vital Capacity (FVC)
Measured: From baseline to day-of-surgery preoperative
Change in Pulse Oximetry
Measured: From baseline to day-of-surgery preoperative
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Measured: From day 1 to postoperative day 3
Change in Forced Vital Capacity (FVC)
Measured: From day 1 to postoperative day 3
Change in Pulse Oximetry
Measured: From day 1 to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start3 May 2022
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Why it stopped: Feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chet Hammill, M.D., MCR, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887922
- Sponsor's protocol ID
- 202105028
- Status last verified
- Apr 2023
- First submitted
- 10 May 2021
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04887922
- Acronym / sponsor ID
- 202105028
- Conditions
- Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility issues
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | No intervention | –-Will not receive a incentive spirometer prior to surgery |
| Pre-Surgery: Standard Incentive Spirometry (IS) | Experimental | Device: Conventional spirometer* Will receive a conventional spirometer prior to surgery * Will be asked to perform spirometry 30 times per day. |
| Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message | Experimental | Device: MIR Spirobank G, Device: ZEPHYRx®* 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. |
| Post-Surgery: Standard Incentive Spirometry (IS) | Active comparator | Device: Conventional spirometer* 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) |
| Post-Surgery: Digital Incentive Spirometry (IS) + Text Message | Experimental | Device: MIR Spirobank G, Device: ZEPHYRx®* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- No access to a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIR Spirobank GFDA-approved, Bluetooth digital spirometer | Device | Post-Surgery: Digital Incentive Spirometry (IS) + Text Message, Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message |
| 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. | Device | Post-Surgery: Digital Incentive Spirometry (IS) + Text Message, Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message |
| Conventional spirometerWill be provided to participants | Device | Post-Surgery: Standard Incentive Spirometry (IS), Pre-Surgery: Standard Incentive Spirometry (IS) |
Primary outcome
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Time frame: From baseline to day-of-surgery preoperative
5 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: From baseline to day-of-surgery preoperative
Change in Pulse Oximetry
Time frame: From baseline to day-of-surgery preoperative
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Time frame: From day 1 to postoperative day 3
Change in Forced Vital Capacity (FVC)
Time frame: From day 1 to postoperative day 3
Change in Pulse Oximetry
Time frame: From day 1 to postoperative day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chet Hammill, M.D., MCR principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIR Spirobank G, ZEPHYRx® and Conventional spirometer in people with Abdominal Surgery, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in One Second Parameter (FEV1) (time frame: From baseline to day-of-surgery preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.