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NCT Number: NCT07496385

Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound

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.

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Key information

Conditions

Ultrasound Guidance Airway Management Subglottic Airway Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 1) Severe cervical deformity, extensive subcutaneous emphysema, thick dressing coverage, or severe obesity that prevents clear visualization of the subglottic region by ultrasound.
  • Coagulopathy (platelets <50×10⁹/L) or active bleeding tendency, which may induce airway bleeding due to suctioning procedures.
  • Presence of organic airway disease or previous cervical surgery history, affecting assessment of the subglottic region.
  • Tracheostomy patients. 5) Patients allergic to ultrasound coupling agents, or those unable to cooperate with cervical ultrasound examination due to severe agitation.
  • 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.
  • History of conditions affecting salivary secretion (e.g., Sjögren's syndrome).

Treatment and study plan

ultrasound-guided suction

Other

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 suction

Other

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 suction

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Positive rate of occult blood in airway mucosa

    Time frame: Daily assessment from randomization up to 7 days.

    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%.

  2. Incidence of airway mucosal injury

    Time frame: Daily assessment from randomization up to 7 days.

    Incidence of airway mucosal injury: Injury rate = Number of injured individuals / Number of enrolled individuals (×100%)

  3. Mechanical ventilation duration

    Time frame: Daily assessment from randomization up to 28 days.

    Mechanical ventilation duration: Time from intubation to extubation (days)

  4. ICU Length of Stay

    Time frame: Daily assessment from randomization up to 28 days.

    ICU Length of Stay: The duration from admission to discharge from the ICU (in days).

  5. 28-day Mortality Rate

    Time frame: Daily assessment from randomization up to 28 days.

    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%).

  6. Aspiration incidence rate

    Time frame: Daily assessment from randomization up to 7 days.

    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%)

Study contacts

Contact information is provided by the study sponsor or research team.

weiqing zhang, Ph.D.

CONTACT

[email protected]

86 18521525300

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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