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

17. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200135
        • Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Fremgangsmåte: 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.
Aktiv komparator: 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.
Fremgangsmåte: 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.
Enhet: Standard Suction Catheter
A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
Aktiv komparator: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Stroke-Associated Pneumonia Within 28 Days
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
28-Day All-Cause Mortality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Pudong New Area Gongli Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

30. juni 2029

Studiet fullført (Antatt)

31. juli 2029

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PW2023A-51-OFST-SAP
  • PW2023A-51 (Annet stipend/finansieringsnummer: Shanghai Pudong New Area Health Commission)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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