Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Noninvasive respiratory support
Treatment groups
1,200 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Collaborator
Catholic University of the Sacred Heart
Collaborator
Source ClinicalTrials.gov