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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management; Ultrasound Guidance; Subglottic Airway Injury
• Intervention / Treatment: Other: ultrasound-guided suction; Other: Continuous subglottic suction; Other: Intermittent subglottic suction

• Study Type: Interventional
• Enrollment (Estimated): 321
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: weiqing zhang, Ph.D.; Phone Number: 86 18521525300; Email: weiq.zh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

  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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-Guided Group; Subglottic suctioning is performed under ultrasound imaging guidance.	Other: ultrasound-guided suction; 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.
Active Comparator: Continuous Suctioning Group; Provide continuous subglottic suction for 24 hours.	Other: Continuous subglottic suction; 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.
Active Comparator: Intermittent Suctioning Group; Intermittent suctioning is performed in accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway'.	Other: Intermittent subglottic suction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily assessment from randomization up to 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	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%)	Daily assessment from randomization up to 7 days.
Mechanical ventilation duration	Mechanical ventilation duration: Time from intubation to extubation (days)	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).	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%).	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%)	Daily assessment from randomization up to 7 days.

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: weiqing Zhang, Ph.D., Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ZWQ21886-2026-EC-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No