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NCT Number: NCT07647666

Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infections Ischemic Stroke Lung Diseases Nervous System Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections Stroke Stroke-Associated Pneumonia (SAP) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences

Shanghai, Shanghai Municipality, 200135, China

Location contact

Qiancheng Luo, MD

CONTACT

[email protected]

+86 13564781737

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oropharyngeal Flushing Suction Tube

Device

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.

Laryngoscope-Guided Oropharyngeal Suction

Procedure

Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.

Standard Suction Catheter

Device

A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.

Conventional Oral or Nasal Suction

Procedure

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 outcomes

  1. Incidence of Stroke-Associated Pneumonia Within 28 Days

    Time frame: Within 28 days after enrollment

    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.

Secondary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: 28 days after enrollment

    Proportion of participants who die from any cause within 28 days after enrollment.

  2. Artificial Airway Establishment or Invasive Mechanical Ventilation

    Time frame: Within 28 days after enrollment

    Proportion of participants requiring endotracheal intubation, tracheostomy, and/or invasive mechanical ventilation due to respiratory failure or airway protection within 28 days after enrollment.

  3. White Blood Cell Count Over Time

    Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21

    Serial white blood cell count values and changes from baseline.

  4. High-Sensitivity C-Reactive Protein Over Time

    Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21

    Serial high-sensitivity C-reactive protein values and changes from baseline.

  5. Procalcitonin Over Time

    Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21

    Serial procalcitonin values and changes from baseline.

  6. Interleukin-6 Over Time

    Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21

    Serial interleukin-6 values and changes from baseline.

  7. Causative Microorganism Distribution

    Time frame: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion

    Causative microorganisms identified by quantitative culture and species identification among participants with suspected or confirmed stroke-associated pneumonia.

  8. Multidrug-Resistant Organism Detection

    Time frame: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion

    Number and proportion of participants with multidrug-resistant organisms identified by antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia.

  9. Procedure-Related Adverse Events

    Time frame: During each procedure and within 28 days after enrollment

    Occurrence of procedure-related adverse events, including mandibular dislocation, dental injury, mucosal abrasion or laceration, laryngospasm, or intra-procedural oxygen desaturation.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiancheng Luo, MD

CONTACT

[email protected]

+86 13564781737

Sponsors and collaborators

Lead sponsor

Shanghai Pudong New Area Gongli Hospital

Other

Registry information

Official study title

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

Acronym: OFST-SAP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 15, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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