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Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia

ConditionsAcute Ischemic StrokeStroke-Associated Pneumonia (SAP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pudong New Area Gongli Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oropharyngeal Flushing Suction Tube

    Device

    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.

  • Laryngoscope-Guided Oropharyngeal Suction

    Procedure/Surgery

    Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.

  • Standard Suction Catheter

    Device

    A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.

  • Conventional Oral or Nasal Suction

    Procedure/Surgery

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Oropharyngeal Flushing Suction Tube Plus LaryngoscopeExperimental treatment 2 interventions
Group B: Standard Suction Tube Plus LaryngoscopeActive comparator 2 interventions
Group C: Conventional Oral or Nasal SuctionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Stroke-Associated Pneumonia Within 28 Days

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.

Time frame
Within 28 days after enrollment

Secondary outcomes

1

28-Day All-Cause Mortality

Proportion of participants who die from any cause within 28 days after enrollment.

Time frame
28 days after enrollment
2

Artificial Airway Establishment or Invasive Mechanical Ventilation

Proportion of participants requiring endotracheal intubation, tracheostomy, and/or invasive mechanical ventilation due to respiratory failure or airway protection within 28 days after enrollment.

Time frame
Within 28 days after enrollment
3

White Blood Cell Count Over Time

Serial white blood cell count values and changes from baseline.

Time frame
Day 0 and Days 3, 7, 10, 14, 18, and 21
4

High-Sensitivity C-Reactive Protein Over Time

Serial high-sensitivity C-reactive protein values and changes from baseline.

Time frame
Day 0 and Days 3, 7, 10, 14, 18, and 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pudong New Area Gongli Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: