Reminder-enhanced Incentive Spirometry Evaluation (RISE)
26 августа 2026 г. обновлено: 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.
Обзор исследования
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
88
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Emily G Helmer, BA
- Номер телефона: (303) 724-2938
- Электронная почта: emily.helmer@cuanschutz.edu
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Alarms are turned ON.
The alarms include a dim light and soft buzz every twenty minutes during waking hours.
|
|
Без вмешательства: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Median IS breaths per hour
Временное ограничение: 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
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Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hypoxemia
Временное ограничение: 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
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From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Ana Fernandez-Bustamante, MD, PhD, University of Colorado, Denver
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- Fernandez-Bustamante A, Parker RA, Frendl G, Lee JW, Nagrebetsky A, Grecu L, Amar D, Tanaka P, Sprung J, Gupta RA, Subramanian B, Giquel J, Eikermann M, Musch G, Nadler JW, Gama de Abreu M, Bartels K, Grover M, Chen LL, Sparling J, Douin DJ, Weingarten T, Wagener G, Thompson BT, Vidal Melo MF; Perioperative Research Network (PRN) Investigators. Perioperative lung expansion and pulmonary outcomes after open abdominal surgery versus usual care in the USA (PRIME-AIR): a multicentre, randomised, controlled, phase 3 trial. Lancet Respir Med. 2025 May;13(5):447-459. doi: 10.1016/S2213-2600(25)00040-2. Epub 2025 Feb 25.
- Eltorai AEM, Baird GL, Pangborn J, Eltorai AS, Antoci V Jr, Paquette K, Connors K, Barbaria J, Smeals KJ, Riley B, Patel SA, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Financial Impact of Incentive Spirometry. Inquiry. 2018 Jan-Dec;55:46958018794993. doi: 10.1177/0046958018794993.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 ноября 2026 г.
Первичное завершение (Оцененный)
31 октября 2028 г.
Завершение исследования (Оцененный)
1 января 2029 г.
Даты регистрации исследования
Первый отправленный
22 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
22 июля 2026 г.
Первый опубликованный (Действительный)
27 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 августа 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 26-1508
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Patient privacy protection
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .