Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
NCT07647666 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-06-18
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.
Conditions
- Acute Ischemic Stroke
- Stroke-Associated Pneumonia (SAP)
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.
Sponsors & Collaborators
-
Shanghai Pudong New Area Gongli Hospital
lead OTHER
Principal Investigators
-
Qiancheng Luo, MD · Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2029-06-30
- Completion
- 2029-07-31
Countries
- China
Study Locations
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