Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noninvasive respiratory support.
- Who it may be relevant to
- Registry conditions: Respiratory Failure, Hypoxemic Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Device Noninvasive respiratory support
Treatment of acute hypoxemic respiratory failure
Primary outcome measures
- Rate of Endotracheal intubation [Time frame: 28 days]
Secondary outcome measures (11)
- Days free of invasive mechanical ventilation at day 28 [Time frame: 28 days]
- Days free of invasive mechanical ventilation at day 60 [Time frame: 60 days]
- Days free of invasive mechanical ventilation at day 90 [Time frame: 90 days]
- Rate of In-intensive care unit mortality [Time frame: 90 days]
- Rate of In-hospital care unit mortality [Time frame: 90 days]
- Rate of 90-day mortality [Time frame: 90 days]
- 90-day ICU free days [Time frame: 90 days]
- 90-day hospital free days [Time frame: 90 days]
- Incidence of pneumonia [Time frame: 90 days]
- Incidence of shock [Time frame: 90 days]
- Incidence of barotrauma [Time frame: 90 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Gemelli — Rome
Identifiers
NCT: NCT05089695 · HENIVOT2