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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT05089695
Eligibility Criteria:
Inclusion Criteria:
* Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA\>2 or left ventricular ejection fraction\<50%); Informed consent
Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded.
Other Exclusion Criteria:
* Pregnancy;
* Exacerbation of asthma or chronic obstructive pulmonary disease;
* Hypercapnia (PaCO2\>45 mmHg) with or without respiratory acidosis;
* More than 2 organ failures, including the lung.
* Documented pneumothorax;
* Clinical diagnosis of Cardiogenic pulmonary edema;
* Haemodynamic instability (Systolic blood pressure\<90 mmHg or mean arterial pressure\<65mmHg) and/or lactic acidosis (lactate\>5 mmol/L) and/or clinically diagnosed Shock requiring administration of vasoactive agents (norepinephrine\>0.1 mcg/Kg/min);
* Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
* Chronic kidney failure requiring dialysis before ICU admission;
* Chronic hypoxemic respiratory failure requiring long-term oxygen therapy;
* Altered neurological status that requires immediate intubation and/or making the patient uncooperative;
* Urgent need for endotracheal intubation, according to the decision of the attending physician;
* Do not intubate order;
* Decision of withdrawal of life-sustaining therapy;
* Thoracic or abdominal surgery in the previous 7 days;
* Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure;
* Recent head surgery or anatomy that prevent the application of helmet or HFNC to patient's face.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05089695
Study Brief:
Protocol Section:
NCT05089695