Ultrasound GuidanceNCT07496385
Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound
A study testing ultrasound-guided suction, Continuous subglottic suction and Intermittent subglottic suction in people with Ultrasound Guidance and Subglottic Airway Injury, run by Ruijin Hospital.
Trial summary
Subglottic suctioning, as an important airway management technique, has its operational accuracy and safety directly impacting patient prognosis. Therefore, improving the effectiveness and safety of subglottic suctioning has become a focus of clinical attention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound Guidance, Subglottic Airway Injury, Airway Management
- What is being tested?
- ultrasound-guided suction, Continuous subglottic suction and Intermittent subglottic suction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Aug 2027
- 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
- 1. Patients admitted to the ICU with the patient or their legal representative having signed an informed consent form; 2. Patients expected to have an oral artificial airway in place for ≥72 hours; 3. Patients using tracheostomy tubes with subglottic suctioning
Who cannot join
- 1) Severe cervical deformity, extensive subcutaneous emphysema, thick dressing coverage, or severe obesity that prevents clear visualization of the subglottic region by ultrasound.
- 2) Coagulopathy (platelets <50×10⁹/L) or active bleeding tendency, which may induce airway bleeding due to suctioning procedures.
- 3) Presence of organic airway disease or previous cervical surgery history, affecting assessment of the subglottic region.
- 4) Tracheostomy patients. 5) Patients allergic to ultrasound coupling agents, or those unable to cooperate with cervical ultrasound examination due to severe agitation.
- 6) Patients with existing pulmonary infection upon admission. 7) Patients intubated for treatment of known aspiration. 8) History of lung cancer or head and neck cancer that may produce alpha-amylase in the lungs.
- 9) History of conditions affecting salivary secretion (e.g., Sjögren's syndrome).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Subglottic suctioning, as an important airway management technique, has its operational accuracy and safety directly impacting patient prognosis. Therefore, improving the effectiveness and safety of subglottic suctioning has become a focus of clinical attention. Point-of-care ultrasound, which can provide imaging, can be used to guide subglottic suctioning, enhancing the intuitiveness of the procedure. This study aims to evaluate the safety and effectiveness of subglottic suctioning guided by point-of-care ultrasound in mechanically ventilated patients, in order to help standardize clinical practice and improve medical quality.
- Being tested
- ultrasound-guided suction, Continuous subglottic suction, Intermittent subglottic suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided suctionOther
In accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway', subglottic suctioning is performed under ultrasound imaging guidance. Based on semi-quantitative assessment of secretions via ultrasound airway examination, suctioning is administered if the score is ≥1. After suctioning is completed, ultrasound re-evaluation is conducted, and the procedure continues until the score equals 0, at which point the operation concludes.
Continuous subglottic suctionOther
Provide continuous subglottic suction for 24 hours by connecting to a central negative pressure device, using constant negative pressure for continuous suction. The suction pressure is maintained at: 40~60 mmHg.
Intermittent subglottic suctionOther
Suction time is the same as that of the ultrasound-guided group. The device uses a bedside wall-mounted negative pressure suction apparatus, with the suction pressure maintained at 100 ~ 150 mmHg (1 mmHg = 0.133 Kpa). The operation is ended based on the operator's experience.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Group | Experimental | Subglottic suctioning is performed under ultrasound imaging guidance. Receives: Other: ultrasound-guided suction |
| Continuous Suctioning Group | Active comparator | Provide continuous subglottic suction for 24 hours. Receives: Other: Continuous subglottic suction |
| Intermittent Suctioning Group | Active comparator | Intermittent suctioning is performed in accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway'. Receives: Other: Intermittent subglottic suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia (VAP)
Incidence of ventilator-associated pneumonia (VAP): The incidence of VAP is calculated as the number of cases divided by the total number of enrolled patients multiplied by 100%. A Chest Physiotherapy and Infection Score (CPIS) of ≥6 is considered indicative of VAP occurrence.
Measured: Daily assessment from randomization up to 7 days.
Secondary outcomes (6)
Positive rate of occult blood in airway mucosa
Positive rate of occult blood in airway mucosa: Positive rate of occult blood test = number of individuals with positive test results / total number of enrolled individuals × 100%.
Measured: Daily assessment from randomization up to 7 days.
Incidence of airway mucosal injury
Incidence of airway mucosal injury: Injury rate = Number of injured individuals / Number of enrolled individuals (×100%)
Measured: Daily assessment from randomization up to 7 days.
Mechanical ventilation duration
Mechanical ventilation duration: Time from intubation to extubation (days)
Measured: Daily assessment from randomization up to 28 days.
ICU Length of Stay
ICU Length of Stay: The duration from admission to discharge from the ICU (in days).
Measured: Daily assessment from randomization up to 28 days.
28-day Mortality Rate
28-day Mortality Rate: The mortality rate refers to the proportion of deaths occurring within 28 days after enrollment. It is calculated as the number of deaths divided by the number of enrolled participants (×100%).
Measured: Daily assessment from randomization up to 28 days.
Aspiration incidence rate
Aspiration incidence rate: Airway aspiration incidence rate = number of patients with low-grade or higher airway aspiration as determined by airway amylase testing / total number of enrolled patients (×100%)
Measured: Daily assessment from randomization up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound GuidanceStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- weiqing Zhang, Ph.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496385
- Sponsor's protocol ID
- ZWQ21886-2026-EC-
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound
- ClinicalTrials.gov ID
- NCT07496385
- Acronym / sponsor ID
- ZWQ21886-2026-EC-
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 27 Mar 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.
Subglottic suctioning, as an important airway management technique, has its operational accuracy and safety directly impacting patient prognosis. Therefore, improving the effectiveness and safety of subglottic suctioning has become a focus of clinical attention. Point-of-care ultrasound, which can provide imaging, can be used to guide subglottic suctioning, enhancing the intuitiveness of the procedure. This study aims to evaluate the safety and effectiveness of subglottic suctioning guided by point-of-care ultrasound in mechanically ventilated patients, in order to help standardize clinical practice and improve medical quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Group | Experimental | Other: ultrasound-guided suctionSubglottic suctioning is performed under ultrasound imaging guidance. |
| Continuous Suctioning Group | Active comparator | Other: Continuous subglottic suctionProvide continuous subglottic suction for 24 hours. |
| Intermittent Suctioning Group | Active comparator | Other: Intermittent subglottic suctionIntermittent suctioning is performed in accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients admitted to the ICU with the patient or their legal representative having signed an informed consent form; 2. Patients expected to have an oral artificial airway in place for ≥72 hours; 3. Patients using tracheostomy tubes with subglottic suctioning
Key exclusion criteria (6 listed)
- 1) Severe cervical deformity, extensive subcutaneous emphysema, thick dressing coverage, or severe obesity that prevents clear visualization of the subglottic region by ultrasound.
- 2) Coagulopathy (platelets <50×10⁹/L) or active bleeding tendency, which may induce airway bleeding due to suctioning procedures.
- 3) Presence of organic airway disease or previous cervical surgery history, affecting assessment of the subglottic region.
- 4) Tracheostomy patients. 5) Patients allergic to ultrasound coupling agents, or those unable to cooperate with cervical ultrasound examination due to severe agitation.
- 6) Patients with existing pulmonary infection upon admission. 7) Patients intubated for treatment of known aspiration. 8) History of lung cancer or head and neck cancer that may produce alpha-amylase in the lungs.
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 |
|---|---|---|
| ultrasound-guided suctionIn accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway', subglottic suctioning is performed under ultrasound imaging guidance. Based on semi-quantitative assessment of secretions via ultrasound airway examination, suctioning is administered if the score is ≥1. After suctioning is completed, ultrasound re-evaluation is conducted, and the procedure continues until the score equals 0, at which point the operation concludes. | Other | Ultrasound-Guided Group |
| Continuous subglottic suctionProvide continuous subglottic suction for 24 hours by connecting to a central negative pressure device, using constant negative pressure for continuous suction. The suction pressure is maintained at: 40~60 mmHg. | Other | Continuous Suctioning Group |
| Intermittent subglottic suctionSuction time is the same as that of the ultrasound-guided group. The device uses a bedside wall-mounted negative pressure suction apparatus, with the suction pressure maintained at 100 ~ 150 mmHg (1 mmHg = 0.133 Kpa). The operation is ended based on the operator's experience. | Other | Intermittent Suctioning Group |
Primary outcome
Incidence of ventilator-associated pneumonia (VAP)
Time frame: Daily assessment from randomization up to 7 days.
Incidence of ventilator-associated pneumonia (VAP): The incidence of VAP is calculated as the number of cases divided by the total number of enrolled patients multiplied by 100%. A Chest Physiotherapy and Infection Score (CPIS) of ≥6 is considered indicative of VAP occurrence.
6 secondary outcomes
Positive rate of occult blood in airway mucosa
Time frame: Daily assessment from randomization up to 7 days.
Incidence of airway mucosal injury
Time frame: Daily assessment from randomization up to 7 days.
Mechanical ventilation duration
Time frame: Daily assessment from randomization up to 28 days.
ICU Length of Stay
Time frame: Daily assessment from randomization up to 28 days.
28-day Mortality Rate
Time frame: Daily assessment from randomization up to 28 days.
Aspiration incidence rate
Time frame: Daily assessment from randomization up to 7 days.
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 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
weiqing Zhang, Ph.D. principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided suction, Continuous subglottic suction and Intermittent subglottic suction in people with Ultrasound Guidance and Subglottic Airway Injury, run by Ruijin Hospital.
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 1 inclusion and 6 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 weiqing zhang, Ph.D. (86 18521525300, weiq.zh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated pneumonia (VAP) (time frame: Daily assessment from randomization up to 7 days.). 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 27 Mar 2026.