Reminder-enhanced Incentive Spirometry Evaluation (RISE)
keskiviikko 26. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
88
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Emily G Helmer, BA
- Puhelinnumero: (303) 724-2938
- Sähköposti: emily.helmer@cuanschutz.edu
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
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Alarms are turned ON.
The alarms include a dim light and soft buzz every twenty minutes during waking hours.
|
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Ei väliintuloa: 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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Median IS breaths per hour
Aikaikkuna: Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)
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Median adequate IS breaths per hour within eligible hours of all patients in each reminder group
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Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Hypoxemia
Aikaikkuna: From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)
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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
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From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Ana Fernandez-Bustamante, MD, PhD, University of Colorado, Denver
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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