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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Rate of Endotracheal intubation
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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
Detailed Description
The optimal initial management of acute hypoxemic respiratory failure is uncertain. Helmet noninvasive ventilation and high-flow nasal oxygen appear as the most promising techniques in this setting. Recently, the first head-to-head randomized trial compared first-line continuous treatment with helmet pressure support ventilation with specific settings (PEEP=12 cmH2O pressure and pressure support=10-12 cmH2O) vs. high-flow nasal oxygen alone in patients with moderate-to-severe hypoxemic respiratory failure. Results showed no significant inter-group difference in the days free of respiratory support at 28 days, but lower intubation rate and increased 28-day invasive ventilation-free days in the helmet group. Use of helmet noninvasive ventilation is less frequent than use of helmet continuous positive airway pressure, which is simpler to use. The investigators designed an open-label, multicentre randomized trial to assess the effect of helmet pressure support ventilation and continuous airway pressure as compared to high-flow nasal oxygen on the intubation rate of patients with moderate-to-severe hypoxemic respiratory failure in the intensive care unit.
Investigators
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.
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;
Outcomes
Primary Outcomes
Rate of Endotracheal intubation
Time Frame: 28 days
The proportion of patients requiring endotracheal intubation according to predefined criteria
Secondary Outcomes
- Rate of In-intensive care unit mortality(90 days)
- Days free of invasive mechanical ventilation at day 28(28 days)
- Days free of invasive mechanical ventilation at day 60(60 days)
- Days free of invasive mechanical ventilation at day 90(90 days)
- Incidence of shock(90 days)
- Incidence of barotrauma(90 days)
- Rate of In-hospital care unit mortality(90 days)
- Rate of 90-day mortality(90 days)
- Incidence of pneumonia(90 days)
- 90-day ICU free days(90 days)
- 90-day hospital free days(90 days)