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Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia (OFST-SAP)

17 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200135
        • Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Dispositivo: 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.
Procedimiento: 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.
Comparador activo: 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.
Procedimiento: 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.
Dispositivo: Standard Suction Catheter
A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
Comparador activo: 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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Stroke-Associated Pneumonia Within 28 Days
Periodo de tiempo: 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.
Within 28 days after enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
28-Day All-Cause Mortality
Periodo de tiempo: 28 days after enrollment
Proportion of participants who die from any cause within 28 days after enrollment.
28 days after enrollment
Artificial Airway Establishment or Invasive Mechanical Ventilation
Periodo de tiempo: 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.
Within 28 days after enrollment
Procedure-Related Adverse Events
Periodo de tiempo: 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.
During each procedure and within 28 days after enrollment
White Blood Cell Count Over Time
Periodo de tiempo: Day 0 and Days 3, 7, 10, 14, 18, and 21
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
Periodo de tiempo: Day 0 and Days 3, 7, 10, 14, 18, and 21
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
Periodo de tiempo: Day 0 and Days 3, 7, 10, 14, 18, and 21
Serial procalcitonin values and changes from baseline.
Day 0 and Days 3, 7, 10, 14, 18, and 21
Interleukin-6 Over Time
Periodo de tiempo: Day 0 and Days 3, 7, 10, 14, 18, and 21
Serial interleukin-6 values and changes from baseline.
Day 0 and Days 3, 7, 10, 14, 18, and 21
Causative Microorganism Distribution
Periodo de tiempo: 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.
On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Multidrug-Resistant Organism Detection
Periodo de tiempo: 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.
On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai Pudong New Area Gongli Hospital

Investigadores

  • Investigador principal: Qiancheng Luo, MD, Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

30 de junio de 2029

Finalización del estudio (Estimado)

31 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PW2023A-51-OFST-SAP
  • PW2023A-51 (Otro número de subvención/financiamiento: Shanghai Pudong New Area Health Commission)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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