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 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT06211920
Eligibility Criteria:
Inclusion Criteria:
1. Age greater than or equal to 18 years.
2. Medical history of COPD.
3. Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
4. Respiratory acidosis with a PaCO2 of \> 6,0 kPa and a pH of \< 7,30.
And one of the following:
5. Respiratory rate of \> 25 per minute.
6. Hypoxia with a PaO2 \< 7 kPa and/or a saturation \< 88% without oxygen administered.
Exclusion Criteria:
1. Upper gastrointestinal hemorrhage or vomiting.
2. Anatomical abnormality that precludes the use of an oro-nasal interface.
3. Suspicion of pneumothorax.
4. Cardiac or respiratory arrest.
5. Uncontrollable malignant arrhythmia.
6. Refractory shock (systolic blood pressure \< 90 mmHg) despite fluids and/or vasoactive drugs given.
7. Required orotracheal intubation.
8. Suspected upper airway obstruction.
9. No indication for life-prolonging treatment with NIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06211920
Study Brief:
Protocol Section:
NCT06211920