Acute Ischemic StrokeOFST-SAPNCT07647666
Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
A study testing Oropharyngeal Flushing Suction Tube, Laryngoscope-Guided Oropharyngeal Suction and Standard Suction Catheter in people with Acute Ischemic Stroke and Stroke-Associated Pneumonia (SAP), run by Shanghai Pudong New Area Gongli Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Stroke-Associated Pneumonia (SAP)
- What is being tested?
- Oropharyngeal Flushing Suction Tube, Laryngoscope-Guided Oropharyngeal Suction and Standard Suction Catheter
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
Shanghai, Shanghai Municipality, 200135
Qiancheng Luo, MD, +86 13564781737, luoqiancheng19@163.com
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Oropharyngeal Flushing Suction Tube, Laryngoscope-Guided Oropharyngeal Suction, Standard Suction Catheter, Conventional Oral or Nasal Suction
- Keywords
- Oropharyngeal Suction, Laryngoscope, Airway Management, Suction Tube, Aspiration Pneumonia
- Medical subject headings
- Ischemic Stroke, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal Flushing Suction TubeDevice
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 SuctionProcedure or surgery
Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.
Standard Suction CatheterDevice
A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
Conventional Oral or Nasal SuctionProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal Flushing Suction Tube Plus Laryngoscope | Experimental | 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. Receives: Device: Oropharyngeal Flushing Suction Tube; Procedure: Laryngoscope-Guided Oropharyngeal Suction |
| Standard Suction Tube Plus Laryngoscope | Active comparator | 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. Receives: Procedure: Laryngoscope-Guided Oropharyngeal Suction; Device: Standard Suction Catheter |
| Conventional Oral or Nasal Suction | Active comparator | 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. Receives: Procedure: Conventional Oral or Nasal Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 28 days after enrollment
Secondary outcomes (9)
28-Day All-Cause Mortality
Proportion of participants who die from any cause within 28 days after enrollment.
Measured: 28 days after enrollment
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.
Measured: Within 28 days after enrollment
White Blood Cell Count Over Time
Serial white blood cell count values and changes from baseline.
Measured: Day 0 and Days 3, 7, 10, 14, 18, and 21
High-Sensitivity C-Reactive Protein Over Time
Serial high-sensitivity C-reactive protein values and changes from baseline.
Measured: Day 0 and Days 3, 7, 10, 14, 18, and 21
Procalcitonin Over Time
Serial procalcitonin values and changes from baseline.
Measured: Day 0 and Days 3, 7, 10, 14, 18, and 21
Interleukin-6 Over Time
Serial interleukin-6 values and changes from baseline.
Measured: Day 0 and Days 3, 7, 10, 14, 18, and 21
Causative Microorganism Distribution
Causative microorganisms identified by quantitative culture and species identification among participants with suspected or confirmed stroke-associated pneumonia.
Measured: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Multidrug-Resistant Organism Detection
Number and proportion of participants with multidrug-resistant organisms identified by antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia.
Measured: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Procedure-Related Adverse Events
Occurrence of procedure-related adverse events, including mandibular dislocation, dental injury, mucosal abrasion or laceration, laryngospasm, or intra-procedural oxygen desaturation.
Measured: During each procedure and within 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to three parallel groups: oropharyngeal flushing suction tube plus laryngoscope, standard suction tube plus laryngoscope, or conventional oral/nasal suction.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong New Area Gongli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiancheng Luo, MD, Shanghai Pudong New Area Gongli Hospital
- Investigators
- Qiancheng Luo, MD, Principal investigator, Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647666
- Sponsor's protocol ID
- PW2023A-51-OFST-SAP
- Other IDs
- PW2023A-51
- Acronym
- OFST-SAP
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Application of an Oropharyngeal Flushing Suction Tube Combined With Laryngoscope for Improving Prognosis in Stroke-Associated Pneumonia: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07647666
- Acronym / sponsor ID
- OFST-SAP / PW2023A-51-OFST-SAP
- Keywords
- Oropharyngeal Suction, Laryngoscope, Airway Management, Suction Tube, Aspiration Pneumonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Pudong New Area Gongli HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to three parallel groups: oropharyngeal flushing suction tube plus laryngoscope, standard suction tube plus laryngoscope, or conventional oral/nasal suction.
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal Flushing Suction Tube Plus Laryngoscope | Experimental | Device: Oropharyngeal Flushing Suction Tube, Procedure: Laryngoscope-Guided Oropharyngeal SuctionParticipants 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. |
| Standard Suction Tube Plus Laryngoscope | Active comparator | Procedure: Laryngoscope-Guided Oropharyngeal Suction, Device: Standard Suction CatheterParticipants 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. |
| Conventional Oral or Nasal Suction | Active comparator | Procedure: Conventional Oral or Nasal SuctionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oropharyngeal Flushing Suction TubeA 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. | Device | Oropharyngeal Flushing Suction Tube Plus Laryngoscope |
| Laryngoscope-Guided Oropharyngeal SuctionDirect laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions. | Procedure or surgery | Oropharyngeal Flushing Suction Tube Plus Laryngoscope, Standard Suction Tube Plus Laryngoscope |
| Standard Suction CatheterA conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice. | Device | Standard Suction Tube Plus Laryngoscope |
| Conventional Oral or Nasal SuctionBlind 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. | Procedure or surgery | Conventional Oral or Nasal Suction |
Primary outcome
Incidence of Stroke-Associated Pneumonia Within 28 Days
Time frame: 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.
9 secondary outcomes
28-Day All-Cause Mortality
Time frame: 28 days after enrollment
Artificial Airway Establishment or Invasive Mechanical Ventilation
Time frame: Within 28 days after enrollment
White Blood Cell Count Over Time
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
High-Sensitivity C-Reactive Protein Over Time
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
Procalcitonin Over Time
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
Interleukin-6 Over Time
Time frame: Day 0 and Days 3, 7, 10, 14, 18, and 21
Causative Microorganism Distribution
Time frame: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Multidrug-Resistant Organism Detection
Time frame: On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
Procedure-Related Adverse Events
Time frame: During each procedure and within 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiancheng Luo, MD principal investigator
Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal Flushing Suction Tube, Laryngoscope-Guided Oropharyngeal Suction and Standard Suction Catheter in people with Acute Ischemic Stroke and Stroke-Associated Pneumonia (SAP), run by Shanghai Pudong New Area Gongli Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiancheng Luo, MD (+86 13564781737, luoqiancheng19@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Stroke-Associated Pneumonia Within 28 Days (time frame: Within 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.