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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT06301035
Eligibility Criteria:
Inclusion Criteria:
1. 19 years of age or older
2. Patients who applied mechanical ventilation treatment for more than 24 hours before the excision
3. Patients who underwent endotracheal intubation rather than tracheal incision
4. Planned extubation after successful spontaneous breathing trial (SBT)
5. Reintubation High Risk Patients: If any of the following conditions are met
1. Age \> 65
2. Acute Physiology and Chronic Health Evaluation(APACHE) II on the day of extubation \> 12
3. Body mass index (BMI) \> 30 kg/m2
4. Inability to deal with respiratory secretions
* improper cough reflex
* If at least three aspirations are required in the 8 hours prior to the discharge
5. Difficult or long delay in mechanical ventilation
* The first attempt to leave the mechanical ventilation failed
6. Charlson Commercial Index (CCI) at least 2 categories of comorbidities
7. Heart failure is the main indication of mechanical ventilation application
8. Moderate to severe chronic obstructive pulmonary disease
9. If there is a problem with airway openness (high risk of developing laryngeal edema)
* a woman
* Oral endotracheal intubation maintenance period of at least 3 days
* Difficult to intubate endotracheally (difficult airway)
10. Long-term mechanical ventilation application: When applied for more than 7 days
Exclusion Criteria:
1. a patient with a tracheostomy tube
2. Contraindicated application of nasal interfaces
* a nasal disorder
3. Continuous positive pressure (CPAP) application contraindications
* pneumothorax, blistering lung disease, head trauma, cranial facial surgery, airway foreign matter, unstable hemodynamics, etc
4. EIT application contraindications
* Patients using implantable electronic medical devices (such as implantable defibrillators, pacemakers or spinal cord stimulators)
* a patient with hyperhidrosis
* a patient whose physical movements are not controlled
* a pregnant woman
* BMI 50 or higher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06301035
Study Brief:
Protocol Section:
NCT06301035