An interventional study of Oropharyngeal Flushing Suction Tube and Laryngoscope-Guided Oropharyngeal Suction in Acute Ischemic Stroke and Stroke-Associated Pneumonia (SAP), sponsored by Shanghai Pudong New Area Gongli Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Shanghai Pudong New Area Gongli Hospital · Not applicable, Interventional, and Prevention
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Shanghai Pudong New Area Gongli Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: Laryngoscope-Guided Oropharyngeal Suction
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 · Device: Standard Suction Catheter
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
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.
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
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jun 2029, 34 months later.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 34 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Pudong New Area Gongli Hospital