Airway Management, Subglottic Airway Injury, Ultrasound Guidance
Conditions
Brief 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. 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.
Interventions
OTHERultrasound-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.
OTHERContinuous 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.
OTHERIntermittent 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.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization and group balance were ensured through 'computer-generated block random sequences'. Strict allocation concealment was achieved via a 'sealed envelope' system, effectively preventing selection bias. Due to the nature of the intervention, patients, operators, and assessors could not be blinded. However, blinding of data analysts was implemented to minimize measurement bias to the greatest extent possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventilator-associated pneumonia (VAP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive rate of occult blood in airway mucosa | 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%. |
| Incidence of airway mucosal injury | Daily assessment from randomization up to 7 days. | Incidence of airway mucosal injury: Injury rate = Number of injured individuals / Number of enrolled individuals (×100%) |
| Mechanical ventilation duration | Daily assessment from randomization up to 28 days. | Mechanical ventilation duration: Time from intubation to extubation (days) |
| ICU Length of Stay | Daily assessment from randomization up to 28 days. | ICU Length of Stay: The duration from admission to discharge from the ICU (in days). |
| 28-day Mortality Rate | 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%). |
| Aspiration incidence rate | 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%) |
Contacts
CONTACTweiqing zhang, Ph.D.
PRINCIPAL_INVESTIGATORweiqing Zhang, Ph.D.
Ruijin Hospital
Outcome results
None listed