ClinicalTrials.gg
Not yet recruitingNCT07728214RISEUpdated Aug 31, 2026

Reminder-enhanced Incentive Spirometry Evaluation

An interventional study of Alarms ON in Hypoxemia, sponsored by University of Colorado, Denver. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypoxemia

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Keywords

  • Incentive Spirometry
  • IS
  • Spirometer
  • InSee Device
  • Postoperative Pulmonary Complications
  • Hypoxia
  • Hypoxemia
  • Breathing Exercises
03

In context

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's planned enrollment of 88 is above the median of 45 across 769 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
88 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • DeviceAlarms ON

    Alarms are turned ON. The alarms include a dim light and soft buzz every twenty minutes during waking hours.

06

What researchers measure

Primary outcomes

  1. Median IS breaths per hour

    Median adequate IS breaths per hour within eligible hours of all patients in each reminder group

    Time frame: Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)

Other outcomes

  1. Hypoxemia

    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

    Time frame: From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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  • Bergin C, Speroni KG, Travis T, Bergin J, Sheridan MJ, Kelly K, Daniel MG. Effect of preoperative incentive spirometry patient education on patient outcomes in the knee and hip joint replacement population. J Perianesth Nurs. 2014 Feb;29(1):20-7. doi: 10.1016/j.jopan.2013.01.009. PubMed 24461279 ↗
  • Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22. PubMed 34676618 ↗
  • Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. doi: 10.7326/0003-4819-144-8-200604180-00011. PubMed 16618957 ↗

Individual participant data

Plan to share: No — Patient privacy protection

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07728214
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Oct 31, 2028 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Aug 31, 2026

Study contacts

Emily G Helmer, BA
Contact
emily.helmer@cuanschutz.edu
(303) 724-2938
Ana Fernandez-Bustamante, MD, PhD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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