Actively Recruiting
Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-30
1200
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
S
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute symptoms of respiratory failure with a PaO2/FiO2 ratio of 200 or less
- PaCO2 less than or equal to 45 mmHg
- No history of chronic respiratory failure
- No moderate to severe cardiac insufficiency (NYHA class 2 or less and left ventricular ejection fraction 50% or more)
- Informed consent given
You will not qualify if you...
- Patients who have received noninvasive ventilation or CPAP continuously for more than 24 hours before screening
- Pregnancy
- Asthma or chronic obstructive pulmonary disease exacerbation
- Hypercapnia (PaCO2 greater than 45 mmHg) with or without respiratory acidosis
- More than two organ failures, including the lungs
- Documented pneumothorax
- Cardiogenic pulmonary edema diagnosis
- Hemodynamic instability (systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg), lactic acidosis (lactate over 5 mmol/L), or shock needing vasoactive drugs
- Metabolic acidosis (pH less than 7.30 with normal or low carbon dioxide levels)
- Chronic kidney failure requiring dialysis before ICU admission
- Chronic hypoxemic respiratory failure requiring long-term oxygen therapy
- Altered neurological status needing immediate intubation or making the patient uncooperative
- Urgent need for endotracheal intubation decided by the attending physician
- Do not intubate order
- Decision to withdraw life-sustaining therapy
- Thoracic or abdominal surgery in the previous 7 days
- Conditions likely to require intubation for reasons other than respiratory failure
- Recent head surgery or facial anatomy preventing use of helmet or high-flow nasal cannula
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gemelli
Rome, Italy
Actively Recruiting
Research Team
D
Domenico Luca Grieco, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here