Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery (Periop HFNO)
Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery: A Randomized Trial
The aim of the study is to assess whether perioperative use of high-flow nasal oxygen (HFNO) during the period from induction of anesthesia until discharge from the post-anesthesia care unit in patients undergoing robotic-assisted surgery reduces perioperative oxygen desaturation, atelectasis formation and postoperative pulmonary complications.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The investigators hypothesize that perioperative HFNO reduces perioperative oxygen desaturation, atelectasis formation and postoperative pulmonary complications in patients undergoing robotic-assisted surgery.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02215
- Beth Israel Deaconess 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:
- Age >= 18
- Undergoing non-emergent, non-cardiac, intra-abdominal, intra-thoracic or pelvic robot-assisted surgery with an expected duration of at least 2 hours under general anesthesia with planned extubation at the end of the procedure
Exclusion Criteria:
- Known pregnancy
- Preoperative intubation or tracheostomy
- Anatomical or clinical conditions precluding the use of high-flow nasal oxygen (severe midface trauma, recent nasal surgery, severe nasal septum deviation, severe nasal deformation)
- Contraindications to electrical impedance tomography (EIT), including inability to place the EIT belt or presence of active implantable electronic devices (e.g., pacemaker or implantable cardioverter-defibrillator)
- Planned postoperative admission to the intensive care unit
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: Control
In the control group, patients will receive standard of care anesthesia treatment, consisting of conventional preoxygenation and no active oxygen delivery during the apneic phase of induction. Following extubation, supplemental oxygen will be administered via face mask and subsequently weaned to standard nasal cannula as per routine clinical practice. |
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Экспериментальный: Intervention
In the intervention group, patients will receive high-flow nasal oxygen starting from induction of anesthesia until intubation, and from extubation until discharge from PACU with weaning of high-flow nasal oxygen during their PACU stay. |
In the intervention group, high-flow nasal oxygen (HFNO) will be initiated at the start of preoxygenation and maintained throughout the apneic phase of induction until successful tracheal intubation. HFNO will be reinitiated immediately prior to extubation and continued throughout the early postoperative period until discharge from the post-anesthesia care unit (PACU). HFNO can be discontinued earlier in the PACU at the discretion of the nurse treating the patient, or upon patient request. HFNO can further be changed to standard of care (standard oxygen mask or standard nasal cannula) at any time at the discretion of the anesthesia provider or PACU nurse. Flow rates and fraction of inspired oxygen (FiO₂) will follow the study protocol (70 liters per minute at 100% O2 for induction of anesthesia, 70 liters per minute at 70% O2 for extubation until 10 minutes after arrival in the PACU with subsequent weaning over the first two hours after PACU arrival). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of perioperative oxygen desaturation
Временное ограничение: Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery
|
Incidence of desaturation between induction of anesthesia and discharge from PACU, measured as SpO2 ≤92% |
Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
End expiratory lung volume (EELV)
Временное ограничение: Assessed at predefined perioperative time points from pre-oxygenation until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery.
|
End expiratory lung volume (EELV), measured as difference between pre-oxygenation to post-induction (5min after intubation) and pre-extubation to post-extubation, and pre-extubation to PACU. EELV will be assessed using electrical impedance tomography. |
Assessed at predefined perioperative time points from pre-oxygenation until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery.
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Time-weighted average of oxygen saturation
Временное ограничение: Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery.
|
Time-weighted average of peripherally measured oxygen saturation, during induction of anesthesia (until intubation), between extubation and arrival in the PACU, and during PACU stay. |
Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery.
|
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Incidence of postoperative pulmonary complications
Временное ограничение: From induction of anesthesia up to postoperative day 3
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Incidence of postoperative pulmonary complications, defined as re-intubation, emergency non-invasive ventilation, pleural effusion or pneumonia |
From induction of anesthesia up to postoperative day 3
|
Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Другие идентификационные номера исследования
- 2026P000304
Планирование данных отдельных участников (IPD)
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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.
продукт, произведенный в США и экспортированный из США.
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