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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT04253405
Eligibility Criteria:
Inclusion Criteria: Sequential adult patients 18 years of age or older admitted to the hospital with pulmonary fibrosis and acute onset of respiratory failure that meets criteria A and B bellow.
A. Pulmonary fibrosis will be defined by all of the criteria below:
* presence of Velcro-type crackles on physical examination
* imaging compatible with pulmonary fibrosis
* diffuse disease on imaging
B. Acute respiratory failure (ARF) will be defined by hypoxemia evidenced by SpO2 \<90% or PaO2 \<60 mmHg in room air and at least two of the criteria below within the last four weeks:
* worsening dyspnea
* worsening breathing effort
* worsening gas exchange (worsening SpO2 or paO2)
* worsening respiratory rate, above 25 irpm
Exclusion Criteria:
* Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;
* Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index \<2L / min / m2 in catheterization of right chambers;
* Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;
* Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;
* Presence of delirium or non-cooperation at the time of randomization;
* Anatomical facial abnormalities;
* Incoercible vomiting or hypersecretion of the airways;
* Use of continuous VNIPP or HFNC for more than 8h before randomization;
* pregnancy;
* Refusal to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04253405
Study Brief:
Protocol Section:
NCT04253405