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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT04693403
Eligibility Criteria:
Inclusion Criteria:
* De novo acute respiratory distress, as defined by dyspnea, use of accessory respiratory muscles, and a respiratory rate of 25 breaths per minute or more,
* Hypoxemia, as defined by a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg or a oxygen saturation by pulse oximetry SpO2/FiO2 ratio \<315 will be considered for inclusion
* Informed consent obtained in accordance with local regulations;
Exclusion Criteria:
* Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease;
* Absolute contraindications to CPAP or HFNC
* Cardiac arrest; severe ventricular arrhythmia; shock defined by the need for vasopressors (dopamine \> 5 microg/kg/min or adrenaline or noradrenaline at any dose)
* Altered consciousness (Coma Glasgow Score below 12 points);
* Do not intubate order, do not resuscitate order, or decision to limit full care taken before obtaining informed consent;
* Refusal to participate, prior enrolment in the trial, participation in another interventional study on respiratory distress;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT04693403
Study Brief:
Protocol Section:
NCT04693403