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HypoxemiaRISENCT07728214

Reminder-enhanced Incentive Spirometry Evaluation

A study testing Alarms ON in people with Hypoxemia, run by University of Colorado, Denver.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypoxemia
What is being tested?
Alarms ON
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 1 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Emily G Helmer, BA contact

(303) 724-2938

emily.helmer@cuanschutz.edu

About this study

Official title: 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.

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.

Conditions
Hypoxemia
Being tested
Alarms ON
Keywords
Incentive Spirometry, IS, Spirometer, InSee Device, Postoperative Pulmonary Complications, Hypoxia, Hypoxemia, Breathing Exercises
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alarms ONDevice

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

Study groups in NCT07728214
Study groupRoleWhat they receive
Alarms ONExperimentalA 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.
Receives: Device: Alarms ON
Alarms OFFNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Median IS breaths per hour

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter, prospective, controlled parallel-group clinical trial with randomization by week of enrollment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728214
Sponsor's protocol ID
26-1508
Acronym
RISE
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Patient privacy protection

Publications

  • Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.

    PubMed 24755786

  • Sprung J, Whalley DG, Falcone T, Wilks W, Navratil JE, Bourke DL. The effects of tidal volume and respiratory rate on oxygenation and respiratory mechanics during laparoscopy in morbidly obese patients. Anesth Analg. 2003 Jul;97(1):268-74, table of contents. doi: 10.1213/01.ane.0000067409.33495.1f.

    PubMed 12818980

  • Blum JM, Maile M, Park PK, Morris M, Jewell E, Dechert R, Rosenberg AL. A description of intraoperative ventilator management in patients with acute lung injury and the use of lung protective ventilation strategies. Anesthesiology. 2011 Jul;115(1):75-82. doi: 10.1097/ALN.0b013e31821a8d63.

    PubMed 21552117

  • Blum JM, Stentz MJ, Dechert R, Jewell E, Engoren M, Rosenberg AL, Park PK. Preoperative and intraoperative predictors of postoperative acute respiratory distress syndrome in a general surgical population. Anesthesiology. 2013 Jan;118(1):19-29. doi: 10.1097/ALN.0b013e3182794975.

    PubMed 23221870

  • Wanderer JP, Ehrenfeld JM, Epstein RH, Kor DJ, Bartz RR, Fernandez-Bustamante A, Vidal Melo MF, Blum JM. Temporal trends and current practice patterns for intraoperative ventilation at U.S. academic medical centers: a retrospective study. BMC Anesthesiol. 2015 Mar 28;15:40. doi: 10.1186/s12871-015-0010-3. eCollection 2015.

    PubMed 25852301

  • PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.

    PubMed 24894577

  • Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.

    PubMed 26332856

  • Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

    PubMed 26947624

  • Campbell MK, Grimshaw JM, Elbourne DR. Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported. BMC Med Res Methodol. 2004 Apr 28;4:9. doi: 10.1186/1471-2288-4-9.

    PubMed 15115554

  • Brown SM, Duggal A, Hou PC, Tidswell M, Khan A, Exline M, Park PK, Schoenfeld DA, Liu M, Grissom CK, Moss M, Rice TW, Hough CL, Rivers E, Thompson BT, Brower RG; National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Mechanically Ventilated Patients in the ICU: A Prospective, Observational Study. Crit Care Med. 2017 Aug;45(8):1317-1324. doi: 10.1097/CCM.0000000000002514.

    PubMed 28538439

  • Li K, Saab R, Bravo M, Mascha EJ, Han Y, Nault R, Olson L, Sessler DI. Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial. Acta Anaesthesiol Scand. 2023 Apr;67(4):440-447. doi: 10.1111/aas.14193. Epub 2023 Jan 13.

    PubMed 36583643

  • Wang R, Haberlen SA, Palella FJ Jr, Mugavero MJ, Margolick JB, Macatangay BJC, Martinez-Maza O, Jacobson LP, Abraham AG. Viremia copy-years and mortality among combination antiretroviral therapy-initiating HIV-positive individuals: how much viral load history is enough? AIDS. 2018 Nov 13;32(17):2547-2556. doi: 10.1097/QAD.0000000000001986.

    PubMed 30379686

  • Wesp JA, Duke MC, Farrell TM. Incentive Spirometry After Bariatric Surgery: Yes or No? JAMA Surg. 2017 May 1;152(5):428. doi: 10.1001/jamasurg.2016.4999. No abstract available.

    PubMed 28097336

  • Hall JC, Tarala R, Harris J, Tapper J, Christiansen K. Incentive spirometry versus routine chest physiotherapy for prevention of pulmonary complications after abdominal surgery. Lancet. 1991 Apr 20;337(8747):953-6. doi: 10.1016/0140-6736(91)91580-n.

    PubMed 1678039

  • Stock MC, Downs JB, Gauer PK, Alster JM, Imrey PB. Prevention of postoperative pulmonary complications with CPAP, incentive spirometry, and conservative therapy. Chest. 1985 Feb;87(2):151-7. doi: 10.1378/chest.87.2.151.

    PubMed 3881226

Questions about this trial

What is this clinical trial studying?

A study testing Alarms ON in people with Hypoxemia, run by University of Colorado, Denver.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily G Helmer, BA ((303) 724-2938, emily.helmer@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median IS breaths per hour (time frame: Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07728214, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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