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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke; Stroke-Associated Pneumonia (SAP)
• Intervention / Treatment: Device: Oropharyngeal Flushing Suction Tube; Procedure: Laryngoscope-Guided Oropharyngeal Suction; Device: Standard Suction Catheter; Procedure: Conventional Oral or 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiancheng Luo, MD; Phone Number: +86 13564781737; Email: luoqiancheng19@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200135
      • Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
      • Contact: Qiancheng Luo, MD; Phone Number: +86 13564781737; Email: luoqiancheng19@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oropharyngeal Flushing Suction Tube Plus Laryngoscope; Participants 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.	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.
Active Comparator: Standard Suction Tube Plus Laryngoscope; Participants 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.	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.
Active Comparator: Conventional Oral or Nasal Suction; Participants 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-Day All-Cause Mortality	Proportion of participants who die from any cause within 28 days after enrollment.	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.	Within 28 days after enrollment
Longitudinal Inflammatory Biomarker Trajectories	Serial values and temporal changes in white blood cell count, high-sensitivity C-reactive protein, procalcitonin, and interleukin-6.	Day 0 and Days 3, 7, 10, 14, 18, and 21
Pathogen Distribution and Multidrug-Resistant Organism Detection	Causative microorganisms and multidrug-resistant organisms identified by quantitative culture, species identification, and antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia.	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.	During each procedure and within 28 days after enrollment

Collaborators and Investigators

• Sponsor: Shanghai Pudong New Area Gongli Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Airway Management; Laryngoscope; Aspiration Pneumonia; Oropharyngeal Suction; Suction Tube
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Stroke; Ischemic Stroke; Pneumonia, Aspiration; Organizations; Health Care Economics and Organizations; Congresses as Topic
• Other Study ID Numbers: PW2023A-51-OFST-SAP; PW2023A-51 (Other Grant/Funding Number: Shanghai Pudong New Area Health Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No