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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
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.
Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.
A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
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.
Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Shanghai, Shanghai Municipality, China
Incidence of Stroke-Associated Pneumonia Within 28 Days
Proportion of participants who meet diagnostic criteria for stroke-associated pneumonia within 28 days after enrollment, adjudicated by blinded outcome assessors using clinical findings, laboratory data, and serial chest imaging.
Time frame: Within 28 days after enrollment
28-Day All-Cause Mortality
Proportion of participants who die from any cause within 28 days after enrollment.
Time frame: 28 days after enrollment
Artificial Airway Establishment or Invasive Mechanical Ventilation
Proportion of participants requiring endotracheal intubation, tracheostomy, and/or invasive mechanical ventilation due to respiratory failure or airway protection within 28 days after enrollment.
Time frame: Within 28 days after enrollment
White Blood Cell Count Over Time
Serial white blood cell count values and changes from baseline.
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
High-Sensitivity C-Reactive Protein Over Time
Serial high-sensitivity C-reactive protein values and changes from baseline.
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
Procalcitonin Over Time
Serial procalcitonin values and changes from baseline.
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
Interleukin-6 Over Time
Serial interleukin-6 values and changes from baseline.
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
Causative Microorganism Distribution
Causative microorganisms identified by quantitative culture and species identification among participants with suspected or confirmed stroke-associated pneumonia.
Time frame: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Multidrug-Resistant Organism Detection
Number and proportion of participants with multidrug-resistant organisms identified by antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia.
Time frame: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Procedure-Related Adverse Events
Occurrence of procedure-related adverse events, including mandibular dislocation, dental injury, mucosal abrasion or laceration, laryngospasm, or intra-procedural oxygen desaturation.
Time frame: During each procedure and within 28 days after enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.