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

Helmet Noninvasive Ventilation vs. Continuous Positive Airway Pressure vs. High-flow Nasal Oxygen as First-line Treatment of Acute Hypoxemic Respiratory Failure (HENIVOT2). An Open-label, Multicentre Randomized Trial

This study is testing whether helmet ventilation, CPAP, or high-flow oxygen can help people with serious breathing problems avoid needing a breathing tube.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Rome)
• Trial ID: NCT05089695 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with acute respiratory failure characterized by a PaO2/FiO2 ratio of 200 or less, without a history of chronic respiratory failure or significant cardiac issues.

Not a fit: Patients with chronic respiratory failure, severe cardiac insufficiency, or those who have already received continuous noninvasive ventilation for over 24 hours prior to screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with hypoxemic respiratory failure, potentially reducing the need for invasive intubation.

How similar studies have performed: Previous studies have shown promising results for helmet noninvasive ventilation compared to other methods, indicating potential for success in this trial.

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.

Where this trial is running

Rome

• Gemelli — Rome, Italy (RECRUITING)

Study contacts

• Principal investigator: Domenico Luca Grieco, MD — Fondazione Policlinico A. Gemelli IRCCS
• Study coordinator: Domenico Luca Grieco, MD

Conditions: Respiratory Failure, Hypoxemic Respiratory Failure, Noninvasive ventilation, High-flow nasal oxygen, Mechanical ventilation