Phase
Condition
Lung Injury
Respiratory Failure
Treatment
Noninvasive respiratory support
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absenceof history of chronic respiratory failure or moderate to severe cardiacinsufficiency (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.
Exclusion
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 arterialpressure<65mmHg) and/or lactic acidosis (lactate>5 mmol/L) and/or clinicallydiagnosed Shock requiring administration of vasoactive agents (norepinephrine>0.1mcg/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 thepatient uncooperative;
Urgent need for endotracheal intubation, according to the decision of the attendingphysician;
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 intubationdue to a reason different from respiratory failure;
Recent head surgery or anatomy that prevent the application of helmet or HFNC topatient's face.
Study Design
Study Description
Connect with a study center
Gemelli
Rome,
ItalySite Not Available
Gemelli
Rome 3169070,
ItalyActive - Recruiting

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