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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT04091269
Eligibility Criteria:
Inclusion Criteria:
Postoperation patients
1. receiving invasive mechanical ventilation due to operation
2. abdominal surgery, orthopedic surgery or gynecological surgery
3. without respiratory system Comorbidity
4. able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.
COPD and ARDS patients
1. receiving invasive mechanical ventilation due to acute respiratory failure
2. able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.
Exclusion Criteria:
1. age \< 18 or \>85 years,
2. tracheostomy at time of inclusion,
3. contra-indication for nasogastric tube insertion (e.g. history of esophageal varices, gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 7 days, INR ratio \> 1.5 , APTT \> 44 s, history of leukemia),
4. neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm),
5. hemodynamic unstable (heart rate \> 140 beats/min, vasopressors required with ≥ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≥ 0.2 μg.kg-1.min-1 norepinephrine),
6. sedation level Richmond Agitation-Sedation Scale (RASS) ≤ -2 or ≥ 2,
7. lack of informed consent and patients included in other intervention study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04091269
Study Brief:
Protocol Section:
NCT04091269