Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure

Recruiting now · Not applicable

Conditions studied: Respiratory Failure, Hypoxemic Respiratory Failure

In brief

Multicenter, open label, three-arm randomized trial to assess the effect of helmet noninvasive ventilation vs. helmet continuous positive airway pressure vs. high-flow nasal oxygen on the rate of endotracheal intubation of patients with acute moderate-to-severe hypoxemic respiratory failure

Key facts

Study ID

NCT05089695

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

1200

Starts

2022-03-01

Expected to finish

2026-06-01

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Gemelli — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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