Incentive Spirometry, Patient Adherence, Postoperative Atelectasis, Postoperative Hypoxemia, Postoperative Pneumonia, Postoperative Pulmonary Complications, Respiratory Insufficiency, Respiratory Therapy
Conditions
Keywords
Incentive Spirometry, Postoperative Pulmonary Complications, Postoperative Standard-Of-Care, standard-of-care after surgery, Deep Breathing, Patient Reminders
Brief summary
The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.
Detailed description
This is a pragmatic single-center alternating cluster study. We will enroll adult patients who require general anesthesia for surgery and receive an incentive spirometry device during their PACU stay. Automatic alarms to perform incentive spirometry will be set to either "ON" or "OFF" in alternating weeks. The hypothesis is that patients receiving automatic audible and visual alarms will have increased rates of adequate incentive spirometry breaths compared to patients receiving no alarms.
Interventions
DEVICEAlarms
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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome collection and data analysis will be performed by investigators blinded to the patient's cluster allocation (alarms "ON" or "OFF").
Intervention model description
This is a pragmatic single-center cluster study of surgical patients receiving incentive spirometry devices during their PACU stay, with either automatic alarms "ON" or "OFF" in alternating weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* be 18 years or older; * have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia; * have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff; * not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the InSee monitor.
Exclusion criteria
* have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor; * have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device); * are a part of a vulnerable population (e.g., pregnant, minors, prisoners).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adequate IS Breaths Achieved in PACU | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAna Fernandez-Bustamante, MD, PhD
University of Colorado School of Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 16 |
| ARISCAT score, intermediate/high risk ARISCAT score, intermediate/high risk | 53 Participants |
| ARISCAT score, intermediate/high risk ARISCAT score, low risk | 64 Participants |
| Race/Ethnicity, Customized White/Caucasian Other | 52 Participants |
| Race/Ethnicity, Customized White/Caucasian White/Caucasian | 67 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 117 |
| other Total, other adverse events | 0 / 89 | 0 / 117 |
| serious Total, serious adverse events | 7 / 89 | 2 / 117 |
Outcome results
None listed