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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT01721434
Eligibility Criteria:
Inclusion Criteria:
* mechanical ventilation \> 3 days
* informed consent
* able to sustain a CPAP trial for 30 minutes
* PaO2/FiO2 ratio \> 200 mmHg
* ventilatory settings: positive end expiratory pressure \<= 10 cmH2O, pressure support \<= 10 cmH2O
Exclusion Criteria:
* pre-existent muscle disease (congenital or acquired) or diseases/disorders known to be associated with myopathy including auto-immune diseases
* pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
* upper airway/esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
* phrenic nerve lesions
* pregnancy, breast feeding
* severe renal failure (serum creatinine \> 150 umol/L)
* severe hepatic failure
* recent (within 5 days) nasal bleeding
* systolic blood pressure \< 120 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01721434
Study Brief:
Protocol Section:
NCT01721434