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| ID | Type | Description | Link |
|---|---|---|---|
| PW2023A-51 | Other Grant/Funding Number | Shanghai Pudong New Area Health Commission |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oropharyngeal Flushing Suction Tube Plus Laryngoscope | Experimental | 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. |
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| Standard Suction Tube Plus Laryngoscope | Active Comparator | 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. |
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| Conventional Oral or Nasal Suction | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiancheng Luo, MD | Contact | +86 13564781737 | luoqiancheng19@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiancheng Luo, MD | Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences | Shanghai | Shanghai Municipality | 200135 | China |
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.
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Participants will be randomized in a 1:1:1 ratio to three parallel groups: oropharyngeal flushing suction tube plus laryngoscope, standard suction tube plus laryngoscope, or conventional oral/nasal suction.
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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.
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| 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. |
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| Standard Suction Catheter | Device | A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice. |
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| 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. |
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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 |
| White Blood Cell Count Over Time | Serial white blood cell count values and changes from baseline. | 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. | Day 0 and Days 3, 7, 10, 14, 18, and 21 |
| Procalcitonin Over Time | Serial procalcitonin values and changes from baseline. | Day 0 and Days 3, 7, 10, 14, 18, and 21 |
| Interleukin-6 Over Time | Serial interleukin-6 values and changes from baseline. | 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. | 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. | 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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