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

N/ANot Yet RecruitingNCT07496385

Ruijin Hospital321 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

321

Conditions

Ultrasound Guidance Subglottic Airway Injury Airway Management

Interventions

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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%.

Time frame: 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%)

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

Mechanical ventilation duration

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

Time frame: 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).

Time frame: 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%).

Time frame: 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%)

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts