Trial Outcomes & Findings for REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU) (NCT NCT06304493)
NCT ID: NCT06304493
Last Updated: 2026-06-30
Results Overview
Rate of adequate incentive spirometry breaths achieved by patients per hour for up to 3 hours during the PACU stay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
231 participants
Primary outcome timeframe
PACU stay (up to 3 hours)
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Alarm "ON" Cohort
The "ON" cohort will receive the standard-of-care instructions for IS and information about the auditory and visual reminders. The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements, from admission to the post-anesthesia care unit (PACU) and until PACU discharge.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
Alarm "OFF" Cohort
The "OFF" cohort will receive only the standard-of-care instructions for IS. The "OFF" patients will receive no signals from the InSee monitor attached to their incentive spirometer.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
129
|
|
Overall Study
COMPLETED
|
89
|
117
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)
Baseline characteristics by cohort
| Measure |
Alarm "ON" Cohort
n=89 Participants
The "ON" cohort will receive the standard-of-care instructions for IS and information about the auditory and visual reminders. The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
Alarm "OFF" Cohort
n=117 Participants
The "OFF" cohort will receive only the standard-of-care instructions for IS. The "OFF" patients will receive no signals from the InSee monitor attached to their incentive spirometer.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 16 • n=20 Participants
|
53 years
STANDARD_DEVIATION 16 • n=20 Participants
|
54 years
STANDARD_DEVIATION 16 • n=40 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=20 Participants
|
66 Participants
n=20 Participants
|
118 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=20 Participants
|
51 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian · White/Caucasian
|
67 Participants
n=20 Participants
|
87 Participants
n=20 Participants
|
154 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian · Other
|
22 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
52 Participants
n=40 Participants
|
|
ARISCAT score, intermediate/high risk
ARISCAT score, intermediate/high risk
|
39 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
92 Participants
n=40 Participants
|
|
ARISCAT score, intermediate/high risk
ARISCAT score, low risk
|
50 Participants
n=20 Participants
|
64 Participants
n=20 Participants
|
114 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: PACU stay (up to 3 hours)Rate of adequate incentive spirometry breaths achieved by patients per hour for up to 3 hours during the PACU stay
Outcome measures
| Measure |
Alarm "ON" Cohort
n=89 Participants
The "ON" cohort will receive the standard-of-care instructions for IS and information about the auditory and visual reminders. The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
Alarm "OFF" Cohort
n=117 Participants
The "OFF" cohort will receive only the standard-of-care instructions for IS. The "OFF" patients will receive no signals from the InSee monitor attached to their incentive spirometer.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
|---|---|---|
|
Rate of Adequate IS Breaths Achieved in PACU
|
3 adequate breaths/hour
Interval 0.0 to 8.0
|
1 adequate breaths/hour
Interval 0.0 to 6.0
|
Adverse Events
Alarm "ON" Cohort
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Alarm "OFF" Cohort
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alarm "ON" Cohort
n=89 participants at risk
The "ON" cohort will receive the standard-of-care instructions for IS and information about the auditory and visual reminders. The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
Alarm "OFF" Cohort
n=117 participants at risk
The "OFF" cohort will receive only the standard-of-care instructions for IS. The "OFF" patients will receive no signals from the InSee monitor attached to their incentive spirometer.
Alarms: The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Opioid-induced respiratory depression
|
0.00%
0/89 • Postoperative day 3
Definitions as described within postoperative day 3
|
0.85%
1/117 • Number of events 1 • Postoperative day 3
Definitions as described within postoperative day 3
|
|
Surgical and medical procedures
Surgical complication
|
3.4%
3/89 • Number of events 3 • Postoperative day 3
Definitions as described within postoperative day 3
|
0.85%
1/117 • Number of events 1 • Postoperative day 3
Definitions as described within postoperative day 3
|
|
Infections and infestations
Infection
|
3.4%
3/89 • Number of events 3 • Postoperative day 3
Definitions as described within postoperative day 3
|
0.00%
0/117 • Postoperative day 3
Definitions as described within postoperative day 3
|
|
Endocrine disorders
Diabetic ketoacidosis
|
1.1%
1/89 • Number of events 1 • Postoperative day 3
Definitions as described within postoperative day 3
|
0.00%
0/117 • Postoperative day 3
Definitions as described within postoperative day 3
|
Other adverse events
Adverse event data not reported
Additional Information
Ana Fernandez-Bustamante, MD, PhD
University of Colorado School of Medicine
Phone: 720-848-6744
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place