Acute Ischemic Stroke, Stroke-Associated Pneumonia (SAP)
Conditions
Keywords
Oropharyngeal Suction, Laryngoscope, Airway Management, Suction Tube, Aspiration Pneumonia
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.
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.
Interventions
DEVICEOropharyngeal 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.
PROCEDURELaryngoscope-Guided Oropharyngeal Suction
Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.
DEVICEStandard Suction Catheter
A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
PROCEDUREConventional 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
Shanghai Pudong New Area Gongli Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Stroke-Associated Pneumonia Within 28 Days | Within 28 days after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-Day All-Cause Mortality | 28 days after enrollment | Proportion of participants who die from any cause within 28 days after enrollment. |
| Artificial Airway Establishment or Invasive Mechanical Ventilation | Within 28 days after enrollment | Proportion of participants requiring endotracheal intubation, tracheostomy, and/or invasive mechanical ventilation due to respiratory failure or airway protection within 28 days after enrollment. |
| White Blood Cell Count Over Time | Day 0 and Days 3, 7, 10, 14, 18, and 21 | Serial white blood cell count values and changes from baseline. |
| High-Sensitivity C-Reactive Protein Over Time | Day 0 and Days 3, 7, 10, 14, 18, and 21 | Serial high-sensitivity C-reactive protein values and changes from baseline. |
| Procalcitonin Over Time | Day 0 and Days 3, 7, 10, 14, 18, and 21 | Serial procalcitonin values and changes from baseline. |
| Interleukin-6 Over Time | Day 0 and Days 3, 7, 10, 14, 18, and 21 | Serial interleukin-6 values and changes from baseline. |
| Causative Microorganism Distribution | On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion | Causative microorganisms identified by quantitative culture and species identification among participants with suspected or confirmed stroke-associated pneumonia. |
| Multidrug-Resistant Organism Detection | On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion | Number and proportion of participants with multidrug-resistant organisms identified by antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia. |
| Procedure-Related Adverse Events | During each procedure and within 28 days after enrollment | Occurrence of procedure-related adverse events, including mandibular dislocation, dental injury, mucosal abrasion or laceration, laryngospasm, or intra-procedural oxygen desaturation. |
Countries
China
Contacts
CONTACTQiancheng Luo, MD
PRINCIPAL_INVESTIGATORQiancheng Luo, MD
Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Outcome results
None listed