Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia

Официальное название

Translational Application of an Oropharyngeal Flushing Suction Tube Combined With Laryngoscope for Improving Prognosis in Stroke-Associated Pneumonia: A Prospective Randomized Controlled Trial

Обзор

Stroke-associated pneumonia is a common and clinically important complication after acute ischemic stroke, especially in non-intubated patients with impaired consciousness and reduced cough or swallowing reflexes. Conventional oral or nasal suction may be insufficient for removing deep oropharyngeal secretions. This prospective randomized controlled trial will evaluate whether a patented oropharyngeal flushing suction tube combined with direct laryngoscopy reduces the 28-day incidence of stroke-associated pneumonia compared with laryngoscope-guided standard suction and conventional oral/nasal suction.

Подробное описание

This is an investigator-initiated, single-center, prospective, three-arm, parallel-group, randomized controlled trial. A total of 120 adult patients with acute ischemic stroke, Glasgow Coma Scale scores of 6 to 12, and no artificial airway or invasive mechanical ventilation at enrollment will be randomized in a 1:1:1 ratio to one of three groups: oropharyngeal flushing suction tube plus laryngoscope, standard suction tube plus laryngoscope, or conventional oral/nasal suction. All groups will receive standard stroke care and routine oral care. The primary outcome is the incidence of stroke-associated pneumonia within 28 days after enrollment. Secondary outcomes include 28-day all-cause mortality, establishment of artificial airway or invasive mechanical ventilation, longitudinal inflammatory biomarkers, pathogen distribution and multidrug-resistant organism detection, and procedure-related adverse events.

Вмешательства

• Устройство Oropharyngeal Flushing Suction Tube
  A patented single-use dual-lumen suction tube designed for simultaneous irrigation and suction of oropharyngeal and deep pharyngeal secretions under direct laryngoscopic visualization. The device includes separate irrigation and suction lumens and allows sterile saline irrigation with simultaneous suction when secretions are tenacious.
• Процедура Laryngoscope-Guided Oropharyngeal Suction
  Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.
• Устройство Standard Suction Catheter
  A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
• Процедура Conventional Oral or Nasal Suction
  Blind oral and/or nasal suctioning performed with a standard suction catheter according to routine clinical practice, without direct laryngoscopic visualization and without use of the oropharyngeal flushing suction tube.

Первичные конечные точки

• Incidence of Stroke-Associated Pneumonia Within 28 Days [Срок оценки: Within 28 days after enrollment]

Вторичные конечные точки (9)

• 28-Day All-Cause Mortality [Срок оценки: 28 days after enrollment]
• Artificial Airway Establishment or Invasive Mechanical Ventilation [Срок оценки: Within 28 days after enrollment]
• White Blood Cell Count Over Time [Срок оценки: Day 0 and Days 3, 7, 10, 14, 18, and 21]
• High-Sensitivity C-Reactive Protein Over Time [Срок оценки: Day 0 and Days 3, 7, 10, 14, 18, and 21]
• Procalcitonin Over Time [Срок оценки: Day 0 and Days 3, 7, 10, 14, 18, and 21]
• Interleukin-6 Over Time [Срок оценки: Day 0 and Days 3, 7, 10, 14, 18, and 21]
• Causative Microorganism Distribution [Срок оценки: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion]
• Multidrug-Resistant Organism Detection [Срок оценки: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion]
• Procedure-Related Adverse Events [Срок оценки: During each procedure and within 28 days after enrollment]

Критерии участия

Критерии включения

• Confirmed acute ischemic stroke by cranial CT or MRI.
• Age 18 years or older.
• Glasgow Coma Scale score of 6 to 12.
• No artificial airway and no requirement for invasive mechanical ventilation at enrollment.
• Written informed consent provided by the participant or legally authorized representative.

Критерии исключения

• Existing artificial airway or invasive mechanical ventilation at ICU admission or screening.
• Pre-existing pulmonary infection at enrollment, or definite extra-pulmonary organ or tissue infection during the study period.
• Hemorrhagic blood disorder, clinically significant coagulopathy, or bleeding risk precluding laryngoscopy.
• Oral or maxillofacial deformity impeding laryngoscope insertion.
• Cervical spine fracture, atlantoaxial instability, or other condition restricting neck extension or movement.
• Confirmed or suspected pregnancy.
• Irreversible critical illness with anticipated survival less than 28 days.
• Uncontrolled hypertension or recurrent malignant arrhythmias.
• Other conditions judged by investigators to make participation unsuitable.

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 · 1 центр

• Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences — Шанхай

Идентификаторы

NCT: NCT07647666 · PW2023A-51-OFST-SAP · PW2023A-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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