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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT03370666
Eligibility Criteria:
Inclusion Criteria:
* Presence of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure;
* 7.25 \< pH \< 7.35;
* Arterial Partial pressure of carbon dioxide (PaCO2) equal or greater than 55 mmHg;
* Age \> 18 years/old
Exclusion Criteria:
* Invasive mechanical ventilation in the last 60 days
* Use of any form of noninvasive ventilation or high flow oxygen through nasal cannula (HFNT) prior to study enrollment after the onset of acute hypercapnic respiratory failure (AHRF);
* Noninvasive home care ventilation;
* Unstable clinical condition (need for vasopressors for \>24 h, acute coronary syndrome or life-threatening arrhythmias);
* Refusal of treatment;
* Agitation (RASS \>= +2) or non-cooperation (Kelly Matthay \>=5);
* Failure of more than two organs;
* Cardiac arrest;
* Respiratory arrest requiring tracheal intubation;
* Recent trauma or burns of the neck and face;
* Pregnancy;
* Refusal of consent;
* Inclusion in other research protocols.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03370666
Study Brief:
Protocol Section:
NCT03370666