Hypoxemia
Conditions
Keywords
Incentive Spirometry, IS, Spirometer, InSee Device, Postoperative Pulmonary Complications, Hypoxia, Hypoxemia, Breathing Exercises
Brief summary
The purpose of this study is to test whether automatic reminders with a light and a soft sound help patients improve deep breathing exercises after surgery. These breathing exercises are routinely done with the help of a plastic device that you attach to your mouth and you take a deep breath. These exercises are routinely recommended after major surgery to improve the oxygen level in your blood and reduce other respiratory problems.
Detailed description
The goal of this project is to evaluate whether automatic reminders increase incentive spirometry performance (IS) and reduce hypoxemia during the first three postoperative days after inpatient non-cardiac surgery in patients with a preoperative ARISCAT risk score ≥26. This three-center pilot study will first test the effectiveness of automatic IS reminders, compared to no reminders, on the quality of performance for three postoperative days after inpatient non-cardiac surgery. Then we will estimate the effect size of IS reminders on postoperative hypoxemia and other complications.
Interventions
DEVICEAlarms ON
Alarms are turned ON. The alarms include a dim light and soft buzz every twenty minutes during waking hours.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The data analyst will be blinded of which participants received breathing exercise reminders and those who did not.
Intervention model description
This is a multicenter, prospective, controlled parallel-group clinical trial with randomization by week of enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years * Planned non-cardiac surgery under general anesthesia with at least one night of hospitalization expected * Preoperative ARISCAT risk score ≥26 * Signed informed consent
Exclusion criteria
* Inability to perform IS due to refusal, cognitive impairment, neuromuscular weakness, anatomical, or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometer) * Have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual IS reminders * Are part of a vulnerable population (minors, pregnant, prisoners) * Lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median IS breaths per hour | Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3) | Median adequate IS breaths per hour within eligible hours of all patients in each reminder group |
Contacts
CONTACTEmily G Helmer, BA
PRINCIPAL_INVESTIGATORAna Fernandez-Bustamante, MD, PhD
University of Colorado, Denver
Outcome results
None listed