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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT06968793
Eligibility Criteria:
Inclusion Criteria:
1. Mechanically ventilated patients who can tolerate pressure support ventilation (PSV) mode;
2. Respiratory stability: Ability to breathe spontaneously and effectively clear secretions via coughing; oxygen saturation (SpO₂) \>90% or a partial pressure of oxygen (PaO₂)/FiO₂ ratio ≥150 mmHg when the ventilator's oxygen concentration is set to 40%;
3. Hemodynamic stability: Heart rate (HR) ≤120 bpm, systolic blood pressure (SBP) 90-150 mmHg, with no vasoactive agents or norepinephrine dosage ≤0.1-0.2 μg/kg·min (or equivalent doses of other vasoactive agents);
4. Metabolic stability, with an esophageal pressure monitoring catheter already placed prior to the trial;
5. Written informed consent obtained from the patient or their legal guardian.
Exclusion Criteria:
1. Age \<18 years;
2. Pregnancy;
3. Hemodynamic instability: Mean arterial pressure (MAP) \<60 mmHg, heart rate (HR) \>120 bpm or \<60 bpm;
4. Respiratory instability: Respiratory rate (RR) \>35 bpm or oxygen saturation (SpO₂) \<90%;
5. Neuromuscular disorders or phrenic nerve injury;
6. Recent trauma or surgery involving the trachea, esophagus, neck, or thorax, contraindications to esophageal catheter insertion, or inability to monitor esophageal pressure;
7. High bleeding risk: Severe coagulopathy/bleeding disorders, esophageal/gastric varices, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06968793
Study Brief:
Protocol Section:
NCT06968793