Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT06911450
Eligibility Criteria:
Phase 1: Feasibility Assessment in Non-Mechanically Ventilated Patients
Inclusion Criteria:
* Adult patients (≥18 years) admitted to the ICU with an APACHE II score \>8.
* Non-mechanically ventilated patients (either spontaneously breathing or receiving only non-invasive oxygen therapy).
Exclusion Criteria:
* History of thoracic surgery or trauma.
* Presence of pneumothorax or chest trauma (e.g., rib fractures, flail chest).
* Pregnancy or age \<18 years.
* Refusal to participate by the patient or legal representative.
* Poor ultrasound image quality (e.g., unclear pleural visualization).
Phase 2: Feasibility Assessment in Mechanically Ventilated Patients
Inclusion Criteria:
* Adult patients (≥18 years) admitted to the ICU with an APACHE II score \>8.
* Receiving invasive mechanical ventilation for \>24 hours.
Exclusion Criteria:
* History of thoracic surgery or trauma.
* Presence of pneumothorax or chest trauma (e.g., rib fractures, flail chest).
* Pregnancy or age \<18 years.
* Requirement for high-frequency oscillatory ventilation.
* Poor ultrasound image quality (e.g., pleural motion obscured by pleural effusion).
Phase 3: Correlation Analysis of Strain and Driving Pressure in Mechanically Ventilated Patients
Inclusion Criteria:
* Adult patients (≥18 years) admitted to the ICU with an APACHE II score \>8.
* Receiving invasive mechanical ventilation for \>24 hours.
* Tolerance to stepwise driving pressure adjustments (10, 15, and 20 cmH₂O, maintained for 10 minutes each).
Exclusion Criteria:
* History of thoracic surgery or trauma.
* Presence of pneumothorax, chest trauma (e.g., rib fractures, flail chest), or significant patient-ventilator asynchrony.
* Pregnancy or age \<18 years.
* Requirement for high-frequency oscillatory ventilation.
* Hemodynamic instability (mean arterial pressure \[MAP\] \<65 mmHg or requiring high-dose vasopressors).
* Severe hypoxemia (PaO₂/FiO₂ \<100 mmHg), precluding safe adjustment of driving pressure.
* Poor ultrasound image quality (e.g., loss of pleural strain signal).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06911450
Study Brief:
Protocol Section:
NCT06911450