Abdominal Surgery
Conditions
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.
Interventions
DEVICEMIR Spirobank G
FDA-approved, Bluetooth digital spirometer
DEVICEZEPHYRx®
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.
DEVICEConventional spirometer
Will be provided to participants
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Forced Expiratory Volume in One Second Parameter (FEV1) | From baseline to day-of-surgery preoperative |
Secondary
| Measure | 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) | From day 1 to postoperative day 3 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) -Will not receive a incentive spirometer prior to surgery | 1 |
| Pre-Surgery: Standard Incentive Spirometry (IS) * Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day. | 1 |
| 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. | 0 |
| 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) | 0 |
| 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 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| 1st Randomization | Decided not to have surgery | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Pre-Surgery: No Incentive Spirometry (IS) | Pre-Surgery: Standard Incentive Spirometry (IS) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 1 |
Outcome results
Primary
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Time frame: From baseline to day-of-surgery preoperative
Population: The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | Baseline | 2.42 L |
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | Day-of-surgery preoperative | 2.46 L |
| Pre-Surgery: Standard Incentive Spirometry (IS) | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | Baseline | 4.07 L |
Secondary
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Time frame: From day 1 to postoperative day 3
Population: Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | Day 1 | 0.58 L |
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Expiratory Volume in One Second Parameter (FEV1) | Day 3 | 1.08 L |
Secondary
Change in Forced Vital Capacity (FVC)
Time frame: From baseline to day-of-surgery preoperative
Population: The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Vital Capacity (FVC) | Baseline | 3.43 L |
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Vital Capacity (FVC) | Day-of-surgery preoperative | 3.23 L |
| Pre-Surgery: Standard Incentive Spirometry (IS) | Change in Forced Vital Capacity (FVC) | Baseline | 4.55 L |
Secondary
Change in Forced Vital Capacity (FVC)
Time frame: From day 1 to postoperative day 3
Population: Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Vital Capacity (FVC) | Day 1 | 1.59 L |
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Forced Vital Capacity (FVC) | Day 3 | 2.09 L |
Secondary
Change in Pulse Oximetry
Time frame: From baseline to day-of-surgery preoperative
Population: The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Pulse Oximetry | Baseline | 99 percentage of oxygen |
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Pulse Oximetry | Day-of-surgery preoperative | 98 percentage of oxygen |
| Pre-Surgery: Standard Incentive Spirometry (IS) | Change in Pulse Oximetry | Baseline | 97 percentage of oxygen |
Secondary
Change in Pulse Oximetry
Time frame: From day 1 to postoperative day 3
Population: Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Pulse Oximetry | Day 1 | 96 percentage of oxygen |
| Pre-Surgery: No Incentive Spirometry (IS) | Change in Pulse Oximetry | Day 3 | 98 percentage of oxygen |