- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07676760
HFNC for Postoperative Atelectasis After Laparoscopic Surgery
The Role of High-Flow Nasal Cannula in Monitoring Postoperative Atelectasis With Lung Ultrasonography After Laparoscopic Surgery: A Prospective Observational Study
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
General anesthesia with laparoscopic surgery causes cephalad diaphragm displacement and reduction in functional residual capacity due to pneumoperitoneum and Trendelenburg positioning, predisposing patients to atelectasis development. Perioperative atelectasis has been reported in up to 90% of patients under general anesthesia, increasing the risk of hypoxemia, prolonged oxygen therapy, and postoperative pulmonary complications (PPCs).
High-flow nasal cannula (HFNC) oxygen therapy supports alveolar recruitment, enhances mucociliary clearance, and may reduce post-extubation atelectasis through heated and humidified gas delivery and generation of low-level positive end-expiratory pressure (PEEP). Randomized controlled trials have demonstrated that HFNC significantly reduces the incidence and severity of atelectasis assessed by LUS in robot-assisted laparoscopic rectal cancer surgery. Lung ultrasonography (LUS) has emerged as a reliable, rapid, and radiation-free method for diagnosis and monitoring of perioperative atelectasis with 87.7% sensitivity and 92.1% specificity.
This study is designed as a prospective, observational, single-center, parallel-group cohort study. No intervention or randomization will be performed. HFNC application will be left entirely to the clinician's discretion; the investigator will not be involved in the treatment process.
Patients in whom HFNC is initiated by the clinician in the post-extubation period will be defined as Group 1 (HFNC group), and patients receiving conventional oxygen therapy will be defined as Group 2 (Control group). HFNC application will be considered valid if initiated within 30 minutes of extubation.
LUS assessments will be performed by an independent investigator blinded to group assignment at four time points: T0 (preoperative), T1 (post-extubation), T2 (30th minute in the recovery unit), and T3 (discharge from the recovery unit). An additional LUS assessment is planned at postoperative 24 hours (T4). The Monastesse modified LUS score will be used at each assessment, evaluating 12 thoracic regions (6 segments per hemithorax along parasternal, anterior axillary, and posterior axillary lines), with a total LUS score ranging from 0 to 36 points.
HFNC parameters (flow rate, FiO₂, duration) and intraoperative variables (type and duration of surgery, anesthesia duration, insufflation duration, pneumoperitoneum pressure, Trendelenburg angle, total fluid intake, urine output) as well as postoperative variables (minimum SpO₂ in the recovery unit, length of hospital stay) will be considered as potential confounding factors in the statistical analysis.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Selvinaz Yüksel Tanrıverdi, MD
- Номер телефона: +0902242955000
- Электронная почта: yukselselvinaz@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients scheduled for elective laparoscopic surgery (general surgery, urology, gynecology)
- Patients undergoing mechanical ventilation under general anesthesia
- ASA physical status I-III
- Patients providing written informed consent
Exclusion Criteria:
- Severe or uncontrolled chronic obstructive pulmonary disease, asthma, or other chronic pulmonary diseases
- Patients with atelectasis or pleural effusion detected on preoperative lung ultrasonography
- Patients requiring intraoperative recruitment maneuver
- ASA physical status IV or above
- Patients receiving spinal or epidural anesthesia
- Cases requiring conversion to laparoscopy or laparotomy
- Patients refusing to participate
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
HFNC Group
Patients in whom high-flow nasal cannula (HFNC) oxygen therapy is initiated by the clinician within 30 minutes of extubation after elective laparoscopic surgery.
|
HFNC Group
|
|
Control Group
Patients receiving conventional oxygen therapy after extubation following elective laparoscopic surgery.
|
Standard oxygen therapy administered via face mask or nasal cannula after extubation following elective laparoscopic surgery.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Total Lung Ultrasonography Score (LUS Score)
Временное ограничение: T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
Total lung ultrasonography score assessed using the Monastesse modified LUS scoring system.
Each hemithorax is divided into 6 segments along parasternal, anterior axillary, and posterior axillary lines, evaluating a total of 12 thoracic regions with a total score ranging from 0 to 36 points.
Scores are compared between HFNC and conventional oxygen therapy groups.
|
T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of Significant Atelectasis
Временное ограничение: T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
Proportion of patients with at least one lung region scoring ≥2 on the LUS scoring system (coalescing B-lines/irregular pleura or consolidation >1×2cm) at each time point.
|
T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
|
Minimum SpO₂ in the Post-Anesthesia Care Unit (PACU)
Временное ограничение: From extubation to PACU discharge, up to 2 hours
|
Minimum oxygen saturation recorded during the entire post-anesthesia care unit stay.
|
From extubation to PACU discharge, up to 2 hours
|
|
Incidence of Hypoxemia
Временное ограничение: From extubation to PACU discharge, up to 2 hours
|
Proportion of patients with SpO₂ below 95% during the post-anesthesia care unit stay.
|
From extubation to PACU discharge, up to 2 hours
|
|
Incidence of Severe Hypoxemia
Временное ограничение: From extubation to PACU discharge, up to 2 hours
|
Proportion of patients with SpO₂ below 90% during the post-anesthesia care unit stay.
|
From extubation to PACU discharge, up to 2 hours
|
|
Postoperative Complications
Временное ограничение: From surgery to hospital discharge, up to 7 days
|
Incidence and type of postoperative complications recorded during hospital stay.
|
From surgery to hospital discharge, up to 7 days
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Han L, Ren D, Zhu M, Pan L, Zhu Y. High-flow nasal cannula oxygen therapy in post-anesthesia care unit (PACU) reduces postextubation atelectasis in patients undergoing esophageal cancer surgery: A randomized controlled trial. PLoS One. 2026 May 5;21(5):e0348511. doi: 10.1371/journal.pone.0348511. eCollection 2026.
- Sun L, Wang J, Wei P, Ruan WQ, Guo J, Yin ZY, Li X, Song JG. Randomized Controlled Trial Investigating the Impact of High-Flow Nasal Cannula Oxygen Therapy on Patients Undergoing Robotic-Assisted Laparoscopic Rectal Cancer Surgery, with a Post-Extubation Atelectasis as a Complication. J Multidiscip Healthc. 2024 Jan 26;17:379-389. doi: 10.2147/JMDH.S449839. eCollection 2024.
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
- BursaYIERHTanriverdi-002
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.
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