Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound

Обзор

Subglottic suctioning, as an important airway management technique, has its operational accuracy and safety directly impacting patient prognosis. Therefore, improving the effectiveness and safety of subglottic suctioning has become a focus of clinical attention. Point-of-care ultrasound, which can provide imaging, can be used to guide subglottic suctioning, enhancing the intuitiveness of the procedure. This study aims to evaluate the safety and effectiveness of subglottic suctioning guided by point-of-care ultrasound in mechanically ventilated patients, in order to help standardize clinical practice and improve medical quality.

Вмешательства

• Другое ultrasound-guided suction
  In accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway', subglottic suctioning is performed under ultrasound imaging guidance. Based on semi-quantitative assessment of secretions via ultrasound airway examination, suctioning is administered if the score is ≥1. After suctioning is completed, ultrasound re-evaluation is conducted, and the procedure continues until the score equals 0, at which poin
• Другое Continuous subglottic suction
  Provide continuous subglottic suction for 24 hours by connecting to a central negative pressure device, using constant negative pressure for continuous suction. The suction pressure is maintained at: 40\~60 mmHg.
• Другое Intermittent subglottic suction
  Suction time is the same as that of the ultrasound-guided group. The device uses a bedside wall-mounted negative pressure suction apparatus, with the suction pressure maintained at 100 \~ 150 mmHg (1 mmHg = 0.133 Kpa). The operation is ended based on the operator's experience.

Первичные конечные точки

• Incidence of ventilator-associated pneumonia (VAP) [Срок оценки: Daily assessment from randomization up to 7 days.]

Вторичные конечные точки (6)

• Positive rate of occult blood in airway mucosa [Срок оценки: Daily assessment from randomization up to 7 days.]
• Incidence of airway mucosal injury [Срок оценки: Daily assessment from randomization up to 7 days.]
• Mechanical ventilation duration [Срок оценки: Daily assessment from randomization up to 28 days.]
• ICU Length of Stay [Срок оценки: Daily assessment from randomization up to 28 days.]
• 28-day Mortality Rate [Срок оценки: Daily assessment from randomization up to 28 days.]
• Aspiration incidence rate [Срок оценки: Daily assessment from randomization up to 7 days.]

Критерии участия

Критерии включения

• 1\. Patients admitted to the ICU with the patient or their legal representative having signed an informed consent form; 2. Patients expected to have an oral artificial airway in place for ≥72 hours; 3. Patients using tracheostomy tubes with subglottic suctioning

Критерии исключения

• 1\) Severe cervical deformity, extensive subcutaneous emphysema, thick dressing coverage, or severe obesity that prevents clear visualization of the subglottic region by ultrasound.

2\) Coagulopathy (platelets <50×10⁹/L) or active bleeding tendency, which may induce airway bleeding due to suctioning procedures.

3\) Presence of organic airway disease or previous cervical surgery history, affecting assessment of the subglottic region.

4\) Tracheostomy patients. 5) Patients allergic to ultrasound coupling agents, or those unable to cooperate with cervical ultrasound examination due to severe agitation.

6\) Patients with existing pulmonary infection upon admission. 7) Patients intubated for treatment of known aspiration. 8) History of lung cancer or head and neck cancer that may produce alpha-amylase in the lungs.

9\) History of conditions affecting salivary secretion (e.g., Sjögren's syndrome).

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07496385 · ZWQ21886-2026-EC-

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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