Comparing helmet ventilation, CPAP, and high-flow oxygen for respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, three-arm randomized trial aims to evaluate the effectiveness of helmet noninvasive ventilation, helmet continuous positive airway pressure (CPAP), and high-flow nasal oxygen in reducing the need for endotracheal intubation in patients suffering from acute moderate-to-severe hypoxemic respiratory failure. The study will assess the intubation rates and days free from respiratory support over a 28-day period. By comparing these three noninvasive respiratory support methods, the trial seeks to identify the most effective initial management strategy for this critical condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gemelli
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Domenico Luca Grieco, MD — Fondazione Policlinico A. Gemelli IRCCS
• Study coordinator: Domenico Luca Grieco, MD
• Email: dlgrieco@outlook.it
• Phone: +393397681623

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.