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

ConditionsUltrasound GuidanceSubglottic Airway InjuryAirway Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

1) Severe cervical deformity, extensive subcutaneous emphysema, thick dressing coverage, or severe obesity that prevents clear visualization of the subglottic region by ultrasound.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound-guided suction

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

321 Participants
are divided into 3 treatment groups
Group A: Ultrasound-Guided GroupExperimental treatment 1 intervention
Group B: Continuous Suctioning GroupActive comparator 1 intervention
Group C: Intermittent Suctioning GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

Mechanical ventilation duration

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

Time frame
Daily assessment from randomization up to 28 days.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: