NCT05089695 Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
| NCT ID | NCT05089695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2022-03-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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.
Contact & Investigator
Domenico Luca Grieco, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico A. Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05089695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05089695 currently recruiting?
Yes, NCT05089695 is actively recruiting participants. Contact the research team at dlgrieco@outlook.it for enrollment information.
Where is the NCT05089695 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05089695 clinical trial?
NCT05089695 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Domenico Luca Grieco, MD at Fondazione Policlinico A. Gemelli IRCCS. The trial plans to enroll 1,200 participants.