Reminder-enhanced Incentive Spirometry Evaluation (RISE)

August 26, 2026 updated by: University of Colorado, Denver

Reminder-enhanced Incentive Spirometry Evaluation (RISE)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alarms ON
A soft buzz and blinking light emitted from the incentive spirometer base attachment (monitor) will go off every twenty minutes during waking hours after major surgery.
Device: Alarms ON
Alarms are turned ON. The alarms include a dim light and soft buzz every twenty minutes during waking hours.
No Intervention: Alarms OFF
The patient will be given an incentive spirometer with the base attachment (monitor). No light or soft buzz will be emitted from the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median IS breaths per hour
Time Frame: 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
Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxemia
Time Frame: From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)
Hypoxemia will be calculated using the trapezoidal rule when PaO₂/FiO₂ < 300. The total time with hypoxemia for each POD will be observed using the area-under-curve (AUC); i.e., the use of the area under the oxygen saturation curve
From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Ana Fernandez-Bustamante, MD, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-1508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy protection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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