Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
OFST-SAP
Translational Application of an Oropharyngeal Flushing Suction Tube Combined With Laryngoscope for Improving Prognosis in Stroke-Associated Pneumonia: A Prospective Randomized Controlled Trial
2 other identifiers
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
Study Completion
Last participant's last visit for all outcomes
July 31, 2029
June 15, 2026
June 1, 2026
2.9 years
June 10, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Within 28 days after enrollment
Secondary Outcomes (5)
28-Day All-Cause Mortality
28 days after enrollment
Artificial Airway Establishment or Invasive Mechanical Ventilation
Within 28 days after enrollment
Longitudinal Inflammatory Biomarker Trajectories
Day 0 and Days 3, 7, 10, 14, 18, and 21
Pathogen Distribution and Multidrug-Resistant Organism Detection
On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Procedure-Related Adverse Events
During each procedure and within 28 days after enrollment
Study Arms (3)
Oropharyngeal Flushing Suction Tube Plus Laryngoscope
EXPERIMENTALParticipants receive standard stroke care and routine oral care plus direct laryngoscope-guided suction using the oropharyngeal flushing suction tube. Sterile saline irrigation of approximately 5 mL may be delivered through the irrigation lumen with simultaneous suction when secretions are tenacious.
Standard Suction Tube Plus Laryngoscope
ACTIVE COMPARATORParticipants receive standard stroke care and routine oral care plus direct laryngoscope-guided suction using a standard single-lumen suction catheter. No oropharyngeal flushing suction tube is used.
Conventional Oral or Nasal Suction
ACTIVE COMPARATORParticipants receive standard stroke care and routine oral care plus conventional blind oral and/or nasal suction using a standard suction catheter. No laryngoscope and no flushing suction tube are used.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Shanghai, Shanghai Municipality, 200135, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the procedural and device intervention, participants' bedside care providers and operators cannot be blinded. Stroke-associated pneumonia diagnosis and adverse event classification will be performed by independent outcome assessors blinded to group allocation.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 15, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Identifiable or raw individual participant data will not be publicly shared. After publication of the primary results, de-identified data may be made available to qualified researchers upon reasonable written request, subject to ethics committee approval and a data-sharing agreement.