Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia (OFST-SAP)
17 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Qiancheng Luo, MD
- Telefonnummer: +86 13564781737
- E-post: luoqiancheng19@163.com
Studieorter
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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-post: luoqiancheng19@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of Stroke-Associated Pneumonia Within 28 Days
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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28-Day All-Cause Mortality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Qiancheng Luo, MD, Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
30 juni 2029
Avslutad studie (Beräknad)
31 juli 2029
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Luftvägsinfektioner
- Infektioner
- Luftvägssjukdomar
- Lungsjukdomar
- Lunginflammation
- Stroke
- Ischemisk stroke
- Lunginflammation, Aspiration
- Organisationer
- Hälsovårdsekonomi och organisationer
- Kongresser som ämne
Andra studie-ID-nummer
- PW2023A-51-OFST-SAP
- PW2023A-51 (Annat bidrag/finansieringsnummer: Shanghai Pudong New Area Health Commission)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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