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Feasibility issues
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | No Intervention | -Will not receive a incentive spirometer prior to surgery | |
| Pre-Surgery: Standard Incentive Spirometry (IS) | Experimental |
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| Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message | Experimental |
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| Post-Surgery: Standard Incentive Spirometry (IS) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIR Spirobank G | Device | FDA-approved, Bluetooth digital spirometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in One Second Parameter (FEV1) | From baseline to day-of-surgery preoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Vital Capacity (FVC) | From baseline to day-of-surgery preoperative | |
| Change in Pulse Oximetry | From baseline to day-of-surgery preoperative | |
| Change in Forced Expiratory Volume in One Second Parameter (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chet Hammill, M.D., MCR | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Surgery: No Incentive Spirometry (IS) | -Will not receive a incentive spirometer prior to surgery |
| FG001 | Pre-Surgery: Standard Incentive Spirometry (IS) |
|
| FG002 | Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message |
|
| FG003 | Post-Surgery: Standard Incentive Spirometry (IS) |
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| FG004 | Post-Surgery: Digital Incentive Spirometry (IS) + Text Message |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Randomization |
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| 2nd Randomization |
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Only 2 participants were enrolled to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Surgery: No Incentive Spirometry (IS) | -Will not receive a incentive spirometer prior to surgery |
| BG001 | Pre-Surgery: Standard Incentive Spirometry (IS) |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available. | Posted | Number | L | From baseline to day-of-surgery preoperative |
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Adverse events and all-cause mortality was tracked from start of spirometry intervention through post-operative Day 3 (approximately 1 month).
Only 1 participant was evaluable to be followed for adverse event collection and all-cause mortality collection. This one participant was randomized to the Pre-Surgery: No Incentive Spirometry (IS) arm and then after surgery randomized to the Post Surgery: Digital Incentive Spirometry (IS) + Text Message arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Surgery: No Incentive Spirometry (IS) | -Will not receive a incentive spirometer prior to surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chet Hammill, M.D., MCR | Washington University School of Medicine | 314-273-1809 | hamillc@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2022 | Mar 2, 2023 | Prot_SAP_000.pdf |
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| Post-Surgery: Digital Incentive Spirometry (IS) + Text Message | Experimental |
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| 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 spirometer | Device | Will be provided to participants |
|
| From day 1 to postoperative day 3 |
| Change in Forced Vital Capacity (FVC) | From day 1 to postoperative day 3 |
| Change in Pulse Oximetry | From day 1 to postoperative day 3 |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Pre-Surgery: Digital Incentive Spirometry (IS) + Text Message |
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| BG003 | Post-Surgery: Standard Incentive Spirometry (IS) |
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| BG004 | Post-Surgery: Digital Incentive Spirometry (IS) + Text Message |
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| BG005 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Change in Forced Vital Capacity (FVC) | The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available. | Posted | Number | L | From baseline to day-of-surgery preoperative |
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| Secondary | Change in Pulse Oximetry | The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available. | Posted | Number | percentage of oxygen | From baseline to day-of-surgery preoperative |
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| Secondary | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery. | Posted | Number | L | From day 1 to postoperative day 3 |
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| Secondary | Change in Forced Vital Capacity (FVC) | Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery. | Posted | Number | L | From day 1 to postoperative day 3 |
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| Secondary | Change in Pulse Oximetry | Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery. | Posted | Number | percentage of oxygen | From day 1 to postoperative day 3 |
|
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|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Pre-Surgery: Standard Incentive Spirometry (IS) |
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| Day-of-surgery preoperative |
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| Day-of-surgery preoperative |
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