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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Noninvasive respiratory support
DeviceTreatment of acute hypoxemic respiratory failure
Treatment groups
1,200 Participants
are divided into 3 treatment groupsGroup A: Helmet Noninvasive ventilation (NIV)Experimental treatment 1 intervention
Group B: Helmet continuous airway pressure (CPAP)Experimental treatment 1 intervention
Group C: High-flow nasal oxygenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Endotracheal intubation
The proportion of patients requiring endotracheal intubation according to predefined criteria
Time frame
28 daysSecondary outcomes
1
Days free of invasive mechanical ventilation at day 28
The number of days in which patients do not receive mechanical ventilation within 28 days from randomization
Time frame
28 days2
Days free of invasive mechanical ventilation at day 60
The number of days in which patients do not receive mechanical ventilation within 60 days from randomization
Time frame
60 days3
Days free of invasive mechanical ventilation at day 90
The number of days in which patients do not receive mechanical ventilation within 60 days from randomization
Time frame
90 days4
Rate of In-intensive care unit mortality
All-cause mortality, assessed at the discharge from the intensive care unit
Time frame
90 daysOther outcomes
1
Safety endpoint-causes of endotracheal intubation
Among patients meeting the primary endpoint, the cause of noninvasive treatment failure (as defined by the predefined intubation criteria)
Time frame
28 days2
Safety endpoint-time to treatment failure
In patients meeting the primary endpoint, the time (hours) from randomization to intubation
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
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