Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia (OFST-SAP)
10. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Qiancheng Luo, MD
- Telefonnummer: +86 13564781737
- E-mail: luoqiancheng19@163.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200135
- Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
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Kontakt:
- Qiancheng Luo, MD
- Telefonnummer: +86 13564781737
- E-mail: luoqiancheng19@163.com
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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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.
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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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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.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Stroke-Associated Pneumonia Within 28 Days
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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28-Day All-Cause Mortality
Tidsramme: 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
Tidsramme: 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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Longitudinal Inflammatory Biomarker Trajectories
Tidsramme: Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial values and temporal changes in white blood cell count, high-sensitivity C-reactive protein, procalcitonin, and interleukin-6.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Pathogen Distribution and Multidrug-Resistant Organism Detection
Tidsramme: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Causative microorganisms and multidrug-resistant organisms identified by quantitative culture, species identification, and 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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Procedure-Related Adverse Events
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
30. juni 2029
Studieafslutning (Anslået)
31. juli 2029
Datoer for studieregistrering
Først indsendt
10. juni 2026
Først indsendt, der opfyldte QC-kriterier
10. juni 2026
Først opslået (Faktiske)
15. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Luftvejsinfektioner
- Infektioner
- Luftvejssygdomme
- Lungesygdomme
- Lungebetændelse
- Slag
- Iskæmisk slagtilfælde
- Lungebetændelse, Aspiration
- Organisationer
- Sundhedsøkonomi og organisationer
- Kongresser som emne
Andre undersøgelses-id-numre
- PW2023A-51-OFST-SAP
- PW2023A-51 (Andet bevillings-/finansieringsnummer: Shanghai Pudong New Area Health Commission)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
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