REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Incentive Spirometry; Postoperative Pulmonary Complications; Respiratory Insufficiency; Postoperative Hypoxemia; Respiratory Therapy; Patient Adherence; Postoperative Pneumonia; Postoperative Atelectasis

Treatments: Device: Alarms

Study type: Interventional

Funder types: Other

Identifiers

NCT06304493

23-2470

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups, including a placebo group

Alarm "ON" Cohort

Experimental group

Description:

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.

Treatment:

Device: Alarms

Alarm "OFF" Cohort

Placebo Comparator group

Description:

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.

Treatment:

Device: Alarms