Trial Outcomes & Findings for Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery (NCT NCT04887922)
NCT ID: NCT04887922
Last Updated: 2023-05-17
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
From baseline to day-of-surgery preoperative
Results posted on
2023-05-17
Participant Flow
Participant milestones
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
* 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
* 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)
* 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
* 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.
|
|---|---|---|---|---|---|
|
1st Randomization
STARTED
|
1
|
1
|
0
|
0
|
0
|
|
1st Randomization
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
1st Randomization
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
2nd Randomization
STARTED
|
0
|
0
|
0
|
0
|
1
|
|
2nd Randomization
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
2nd Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
* 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
* 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)
* 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
* 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.
|
|---|---|---|---|---|---|
|
1st Randomization
Decided not to have surgery
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
n=1 Participants
* 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
* 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)
* 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
* 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.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
1 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
1 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
1 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
—
|
—
|
2 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From baseline to day-of-surgery preoperativePopulation: The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available.
Outcome measures
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
n=1 Participants
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Baseline
|
2.42 L
|
4.07 L
|
|
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Day-of-surgery preoperative
|
2.46 L
|
—
|
SECONDARY outcome
Timeframe: From baseline to day-of-surgery preoperativePopulation: The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available.
Outcome measures
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
n=1 Participants
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
Baseline
|
3.43 L
|
4.55 L
|
|
Change in Forced Vital Capacity (FVC)
Day-of-surgery preoperative
|
3.23 L
|
—
|
SECONDARY outcome
Timeframe: From baseline to day-of-surgery preoperativePopulation: The participant in the Pre-Surgery: Standard Incentive Spirometry arm only had baseline data available.
Outcome measures
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
n=1 Participants
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
|
|---|---|---|
|
Change in Pulse Oximetry
Baseline
|
99 percentage of oxygen
|
97 percentage of oxygen
|
|
Change in Pulse Oximetry
Day-of-surgery preoperative
|
98 percentage of oxygen
|
—
|
SECONDARY outcome
Timeframe: From day 1 to postoperative day 3Population: Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery.
Outcome measures
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Day 1
|
0.58 L
|
—
|
|
Change in Forced Expiratory Volume in One Second Parameter (FEV1)
Day 3
|
1.08 L
|
—
|
SECONDARY outcome
Timeframe: From day 1 to postoperative day 3Population: Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery.
Outcome measures
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
Day 1
|
1.59 L
|
—
|
|
Change in Forced Vital Capacity (FVC)
Day 3
|
2.09 L
|
—
|
SECONDARY outcome
Timeframe: From day 1 to postoperative day 3Population: Only 1 participant is evaluable for this outcome measure as the other enrolled participant did not receive surgery.
Outcome measures
| Measure |
Pre-Surgery: No Incentive Spirometry (IS)
n=1 Participants
-Will not receive a incentive spirometer prior to surgery
|
Pre-Surgery: Standard Incentive Spirometry (IS)
* Will receive a conventional spirometer prior to surgery
* Will be asked to perform spirometry 30 times per day.
|
|---|---|---|
|
Change in Pulse Oximetry
Day 1
|
96 percentage of oxygen
|
—
|
|
Change in Pulse Oximetry
Day 3
|
98 percentage of oxygen
|
—
|
Adverse Events
Pre-Surgery: No Incentive Spirometry (IS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-Surgery: Standard Incentive Spirometry (IS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-Surgery: Digital Incentive Spirometry (IS) + Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chet Hammill, M.D., MCR
Washington University School of Medicine
Phone: 314-273-1809
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place