Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy

Официальное название

Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial

Обзор

Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.

Вмешательства

• Устройство High-flow nasal cannula
  Using High-flow nasal cannula oxygenation
• Устройство Regular Nasal Cannula
  Using regular nasal cannula for oxygenation

Первичные конечные точки

• The incidence of hypoxemia [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Вторичные конечные точки (4)

• The incidence of sub-clinical respiratory depression [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
• The incidence of severe hypoxia [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
• Incidence of Other Adverse Events (Excluding Respiratory-Related) [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
• Incidence of Other Respiratory-Related Adverse Events [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Критерии участия

Критерии включения

• 1 year ≤ age ≤ 6 years,
• Weight ≥ 10 kg,
• Undergoing elective sedated bronchoscopy,
• Expected procedure duration ≤ 45 minutes,
• Written informed consent obtained from the subject's legal guardian.

Критерии исключения

• preoperative SpO₂ < 95% on room air,
• Already sedated and tracheally intubated,
• Known history of pneumothorax, known congenital or acquired upper airway abnormalities (e.g., nasopharyngeal structural anomalies), or history of difficult airway,
• Coagulation disorders or predisposition to oral/nasal bleeding, mucosal injury, or space-occupying lesions,
• Severe cardiac insufficiency (< 4 METs), severe renal insufficiency (requiring dialysis), diagnosed severe hepatic insufficiency, Increased intracranial pressure, or ASA classification ≥ IV,
• Allergy to propofol or sufentanil,
• Multiple traumatic injuries,
• Current participation in another clinical trial,
• Other conditions deemed unsuitable by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 4 центра

• Children's Hospital, Zhejiang University School of Medicine — Ханчжоу
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou
• Children's Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07563075 · ZJU2025C226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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