Протоколизированная отмена высокопоточного назального канюля у взрослых пациентов: Поэтапное клиническое исследование с кластерной рандомизацией (PRO-WEAN HFNC)
Протоколизированное отлучение от высокопоточной назальной канюли у взрослых пациентов: ступенчатое клистерное рандомизированное исследование (PRO-WEAN HFNC)
High-flow nasal cannula (HFNC) is a type of oxygen therapy commonly used in adults with breathing problems. While HFNC can help patients avoid breathing tubes and improve oxygen levels, there is no standard method for deciding how and when to reduce and stop this therapy once a patient improves. In many hospitals, these decisions vary from clinician to clinician.
This study will compare usual care with a standardized step-by-step plan for reducing HFNC support. Eight hospitals will participate and will switch from usual care to the standardized plan at different time points during the study.
The main goal is to determine whether the standardized weaning plan increases the number of patients who can successfully stop HFNC within 5 days. The study will also evaluate how long patients remain on HFNC, whether they need additional breathing support, and how long they stay in the hospital.
The results may help develop clearer guidance for safely and efficiently stopping HFNC therapy.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
High-flow nasal cannula (HFNC) therapy has become a standard treatment for acute hypoxemic respiratory failure. Although evidence supports its use for improving oxygenation and reducing intubation risk, guidance on how to discontinue HFNC remains limited. Current weaning practices are highly variable across institutions and clinicians. This variability may contribute to either premature discontinuation, leading to respiratory deterioration, or prolonged therapy, which may delay ICU discharge and increase healthcare utilization.
This trial evaluates implementation of a standardized HFNC weaning protocol across multiple hospitals using a stepped-wedge cluster randomized design. The intervention focuses on structured, progressive reduction of HFNC flow and fraction of inspired oxygen (FiO₂), with predefined criteria for discontinuation and re-escalation of support.
The stepped-wedge approach allows sequential implementation of the protocol across participating hospitals while accounting for secular trends and inter-site practice variability. The study is designed to determine whether protocolized weaning improves efficiency and clinical outcomes compared with usual care.
Findings from this trial are intended to inform evidence-based guidance for HFNC liberation strategies in adult patients with acute hypoxemic respiratory failure.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jie Li, PhD
- Номер телефона: 13125634643
- Электронная почта: Jie_Li@rush.edu
Места учебы
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-
Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Rush University Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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Adult patients ≥ 18 years
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Receiving HFNC for ≥12 hours
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Receiving HFNC to treat acute hypoxemic respiratory failure, defined as requirement of FIO2 ≥ 0.5 to maintain SpO2 at 90-97% and Evidence of increased work of breathing at initiation (e.g., tachypnea with respiratory rate > 20-25/min, or accessory muscle use), including:
- Patients using HFNC to avoid intubation
- Post-extubated patients who develop acute hypoxemic respiratory failure, regardless of respiratory support device prior to HFNC use.
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The bedside clinical team determines that HFNC weaning is clinically appropriate
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Demonstrates clinical stability, defined as:
- Respiratory rate ≤ 25 breaths per minute without use of accessory respiratory muscles
- SpO₂ > 90% on HFNC
- HFNC FiO₂ ≤ 0.80
Exclusion Criteria:
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• Planned procedures requiring intubation
- Hypercapnia (PaCO2 ≥ 45 mmHg)
- Receiving extracorporeal membrane oxygenation (ECMO)
- Receiving continuous aerosol therapy via HFNC (e.g., inhaled nitric oxide [iNO], epoprostenol, or continuous albuterol)
- Receiving chronic home use of HFNC, CPAP, or noninvasive ventilation therapy to treat chronic respiratory failure
- Receiving HFNC as preventative post-extubation therapy, defined as HFNC use immediately after extubation for less than 48 hr in the absence of clinical signs of respiratory failure.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Usual Care HFNC Weaning
During this phase, high-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard practice without a mandated protocol. Decisions regarding reduction of flow and fraction of inspired oxygen (FiO₂), transition to conventional oxygen therapy, and re-escalation of support are made at the discretion of the treating clinical team. |
High-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard clinical practice without a mandated protocol. Decisions regarding reduction of flow and fraction of inspired oxygen (FiO₂), transition to conventional oxygen therapy, and escalation of respiratory support are made at the discretion of the treating clinical team. |
|
Экспериментальный: Protocolized HFNC Weaning
Participants receive a standardized HFNC weaning protocol consisting of structured, stepwise reduction of flow and FiO₂ with predefined criteria for discontinuation and criteria for treatment failure requiring re-escalation of respiratory support. The protocol is implemented at the hospital level during the intervention phase of the stepped-wedge design. |
A standardized high-flow nasal cannula (HFNC) weaning protocol consisting of structured, stepwise reduction of flow and fraction of inspired oxygen (FiO₂) with predefined criteria for discontinuation and predefined criteria for treatment failure requiring re-escalation of respiratory support. The protocol is implemented at the hospital level during the intervention phase of the stepped-wedge cluster randomized design. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
Временное ограничение: Up to 5 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and breathing on conventional oxygen therapy or room air without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. Participants remaining on HFNC beyond Day 5 are considered weaning failures. |
Up to 5 days after study enrollment
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of participants successfully weaned from HFNC by Day 1
Временное ограничение: Up to 1 day after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 1 day after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 2
Временное ограничение: Up to 2 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 2 days after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 3
Временное ограничение: Up to 3 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 3 days after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 4
Временное ограничение: Up to 4 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 4 days after study enrollment
|
|
Proportion of participants successfully weaned from HFNC by Day 7
Временное ограничение: Up to 7 days after study enrollment
|
HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. |
Up to 7 days after study enrollment
|
|
HFNC duration (hours)
Временное ограничение: From HFNC initiation until hospital discharge, up to 28 days
|
Total duration of high-flow nasal cannula (HFNC) therapy measured in hours from initiation of HFNC until permanent discontinuation of HFNC during the hospitalization. |
From HFNC initiation until hospital discharge, up to 28 days
|
|
Oxygen-free days through Day 28
Временное ограничение: Up to 28 days after study enrollment
|
Number of days alive and not receiving any supplemental oxygen (including HFNC, conventional oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation) during the first 28 days after study enrollment. Participants who die before Day 28 will be assigned zero oxygen-free days. |
Up to 28 days after study enrollment
|
|
HFNC Weaning Duration
Временное ограничение: From study enrollment until HFNC discontinuation, up to 28 days
|
Duration in hours from study enrollment to permanent discontinuation of high-flow nasal cannula therapy among participants who meet criteria for weaning success. |
From study enrollment until HFNC discontinuation, up to 28 days
|
|
Proportion of participants requiring noninvasive ventilation within 48 hours after HFNC discontinuation
Временное ограничение: Within 48 hours after HFNC discontinuation
|
Proportion of participants who require initiation of noninvasive ventilation (e.g., BiPAP or CPAP for respiratory failure) within 48 hours after HFNC discontinuation. |
Within 48 hours after HFNC discontinuation
|
|
Proportion of participants requiring re-initiation of HFNC within 48 hours after discontinuation
Временное ограничение: Within 48 hours after HFNC discontinuation
|
Proportion of participants who require re-initiation of high-flow nasal cannula therapy within 48 hours after initial discontinuation. |
Within 48 hours after HFNC discontinuation
|
|
Proportion of participants requiring invasive mechanical ventilation within 48 hours after HFNC discontinuation
Временное ограничение: Within 48 hours after HFNC discontinuation
|
Proportion of participants who require endotracheal intubation and invasive mechanical ventilation within 48 hours after HFNC discontinuation. |
Within 48 hours after HFNC discontinuation
|
|
Duration of invasive mechanical ventilation (hours)
Временное ограничение: During hospitalization, up to 28 days after enrollment
|
Total duration of invasive mechanical ventilation measured in hours from initiation of endotracheal intubation until successful extubation during hospitalization. |
During hospitalization, up to 28 days after enrollment
|
|
ICU Length of Stay
Временное ограничение: During index hospitalization, up to 28 days after enrollment
|
Number of days from ICU admission to ICU discharge during the index hospitalization |
During index hospitalization, up to 28 days after enrollment
|
|
Hospital length of stay (days)
Временное ограничение: During index hospitalization, up to 28 days after enrollment
|
Number of days from hospital admission to hospital discharge during the index hospitalization. |
During index hospitalization, up to 28 days after enrollment
|
|
ICU mortality
Временное ограничение: During ICU stay, up to 28 days after enrollment
|
Proportion of participants who die during the ICU stay. |
During ICU stay, up to 28 days after enrollment
|
|
Hospital mortality
Временное ограничение: During hospitalization, up to 28 days after enrollment
|
Proportion of participants who die during the index hospitalization. |
During hospitalization, up to 28 days after enrollment
|
|
Adverse events related to HFNC therapy
Временное ограничение: During hospitalization, up to 28 days after enrollment
|
Incidence of adverse events during HFNC therapy, including but not limited to skin breakdown, nasal or facial injury, epistaxis, or other clinically significant complications documented during hospitalization. |
During hospitalization, up to 28 days after enrollment
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HFNC weaning
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified individual participant data underlying the results reported in the publication (including data dictionaries) will be made available to qualified researchers upon reasonable request and with appropriate institutional ethics approval after publication of the primary results. Requests must include a methodologically sound research proposal and will require approval by the study investigators and participating institutions. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with institutional and regulatory policies.
Сроки обмена IPD
Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
Критерии совместного доступа к IPD
Access to de-identified individual participant data, data dictionaries, statistical analysis plan, and analytic code will be granted to qualified researchers who submit a methodologically sound research proposal. Requests must receive approval from the study investigators and participating institutions and obtain appropriate institutional ethics approval. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with institutional and regulatory requirements.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .