Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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.
• Procedure 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.
• Device Standard Suction Catheter
  A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
• Procedure 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.

Primary outcome measures

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

Secondary outcome measures (9)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗