Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia (OFST-SAP)
17 juin 2026 mis à jour par: Qiancheng Luo, MD, Shanghai Pudong New Area Gongli Hospital
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Qiancheng Luo, MD
- Numéro de téléphone: +86 13564781737
- E-mail: luoqiancheng19@163.com
Lieux d'étude
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200135
- Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
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Contact:
- Qiancheng Luo, MD
- Numéro de téléphone: +86 13564781737
- E-mail: luoqiancheng19@163.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Confirmed acute ischemic stroke by cranial CT or MRI.
- Age 18 years or older.
- Glasgow Coma Scale score of 6 to 12.
- No artificial airway and no requirement for invasive mechanical ventilation at enrollment.
- Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
- Existing artificial airway or invasive mechanical ventilation at ICU admission or screening.
- Pre-existing pulmonary infection at enrollment, or definite extra-pulmonary organ or tissue infection during the study period.
- Hemorrhagic blood disorder, clinically significant coagulopathy, or bleeding risk precluding laryngoscopy.
- Oral or maxillofacial deformity impeding laryngoscope insertion.
- Cervical spine fracture, atlantoaxial instability, or other condition restricting neck extension or movement.
- Confirmed or suspected pregnancy.
- Irreversible critical illness with anticipated survival less than 28 days.
- Uncontrolled hypertension or recurrent malignant arrhythmias.
- Other conditions judged by investigators to make participation unsuitable.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: 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.
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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.
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Comparateur actif: 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.
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Stroke-Associated Pneumonia Within 28 Days
Délai: Within 28 days after enrollment
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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.
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Within 28 days after enrollment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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28-Day All-Cause Mortality
Délai: 28 days after enrollment
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Proportion of participants who die from any cause within 28 days after enrollment.
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28 days after enrollment
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Artificial Airway Establishment or Invasive Mechanical Ventilation
Délai: Within 28 days after enrollment
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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.
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Within 28 days after enrollment
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Procedure-Related Adverse Events
Délai: During each procedure and within 28 days after enrollment
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Occurrence of procedure-related adverse events, including mandibular dislocation, dental injury, mucosal abrasion or laceration, laryngospasm, or intra-procedural oxygen desaturation.
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During each procedure and within 28 days after enrollment
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White Blood Cell Count Over Time
Délai: Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial white blood cell count values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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High-Sensitivity C-Reactive Protein Over Time
Délai: Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial high-sensitivity C-reactive protein values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Procalcitonin Over Time
Délai: Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial procalcitonin values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Interleukin-6 Over Time
Délai: Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial interleukin-6 values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Causative Microorganism Distribution
Délai: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Causative microorganisms identified by quantitative culture and species identification among participants with suspected or confirmed stroke-associated pneumonia.
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On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Multidrug-Resistant Organism Detection
Délai: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Number and proportion of participants with multidrug-resistant organisms identified by antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia.
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On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Qiancheng Luo, MD, Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
30 juin 2029
Achèvement de l'étude (Estimé)
31 juillet 2029
Dates d'inscription aux études
Première soumission
10 juin 2026
Première soumission répondant aux critères de contrôle qualité
10 juin 2026
Première publication (Réel)
15 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Infections des voies respiratoires
- Infections
- Maladies des voies respiratoires
- Maladies pulmonaires
- Pneumonie
- Accident vasculaire cérébral
- AVC ischémique
- Pneumonie, Aspiration
- Organisations
- Économie et organisations des soins de santé
- Les congrès comme sujet
Autres numéros d'identification d'étude
- PW2023A-51-OFST-SAP
- PW2023A-51 (Autre subvention/numéro de financement: Shanghai Pudong New Area Health Commission)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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