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Набор скоро начнётся NCT07676760

HFNC for Postoperative Atelectasis After Laparoscopic Surgery

Наблюдательное Postoperative Atelectasis Postoperative Pulmonary Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-Flow Nasal Cannula (HFNC), Conventional Oxygen Therapy.
Кому может быть актуально
Состояния в реестре: Postoperative Atelectasis, Postoperative Pulmonary Complications. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Role of High-Flow Nasal Cannula in Monitoring Postoperative Atelectasis With Lung Ultrasonography After Laparoscopic Surgery: A Prospective Observational Study

Обзор

Pneumoperitoneum and Trendelenburg positioning during laparoscopic surgery promote atelectasis development, which has been reported in up to 90% of patients under general anesthesia and increases the risk of postoperative pulmonary complications. High-flow nasal cannula (HFNC) oxygen therapy may reduce post-extubation atelectasis through alveolar recruitment. This prospective observational cohort study aims to evaluate the role of HFNC in postoperative atelectasis monitored by lung ultrasonography (LUS) in patients undergoing elective laparoscopic surgery.

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.

Вмешательства

  • Другое High-Flow Nasal Cannula (HFNC)
    HFNC Group
  • Другое Conventional Oxygen Therapy
    Standard oxygen therapy administered via face mask or nasal cannula after extubation following elective laparoscopic surgery.

Первичные конечные точки

  • Total Lung Ultrasonography Score (LUS Score) [Срок оценки: T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit]
Вторичные конечные точки (5)
  • Incidence of Significant Atelectasis [Срок оценки: 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) [Срок оценки: From extubation to PACU discharge, up to 2 hours]
  • Incidence of Hypoxemia [Срок оценки: From extubation to PACU discharge, up to 2 hours]
  • Incidence of Severe Hypoxemia [Срок оценки: From extubation to PACU discharge, up to 2 hours]
  • Postoperative Complications [Срок оценки: From surgery to hospital discharge, up to 7 days]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

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. PMID 42085443
  • 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. PMID 38292922

Идентификаторы

NCT: NCT07676760 · BursaYIERHTanriverdi-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗