Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure (HENIVOT2)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Respiratory Failure; Hypoxemic Respiratory Failure

Treatments: Device: Noninvasive respiratory support

Study type: Interventional

Funder types: Other

Identifiers

NCT05089695

HENIVOT2

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 3 patient groups

Helmet Noninvasive ventilation (NIV)

Experimental group

Description:

Patients in helmet noninvasive ventilation group will receive continuous helmet pressure support ventilation for at least 16 hours/day in the first 2 calendar days. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference. Each patient will be connected to a mechanical ventilator ventilator through a bitube circuit with no humidification. The ventilator will be set in PSV-NIV mode, with the following suggested settings \[34-38\]: 1. initial pressure support=12 cmH2O and adequate to permit a peak inspiratory flow of 100 l/min; 2. positive end-expiratory pressure=12 cmH2O. 3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. 4. Inspiratory flow trigger = 2 l/min or according to the practice of each institution; 5. fastest pressurization time; 6. expiratory trigger: 10-50% of the maximum inspiratory flow, eventually modified to avoid double triggering; 7. maximum inspiratory time 1.2 second.

Treatment:

Device: Noninvasive respiratory support

Helmet continuous airway pressure (CPAP)

Experimental group

Description:

Patients in CPAP group will receive continuous helmet CPAP for at least 16 hours/day in the first 2 calendar days. Continuous CPAP without interruptions will be strongly encouraged in the first 48 hours of treatment. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference. Treatment will be delivered through a high-flow generator. The following settings will be applied: 1. Continuous air flow\>45 l/min. 2. Bi-tube circuit with no humidification, Y-piece with heat and moisture exchanger, or active heating and humidification with humidification chamber temperature set at 31 °C, 34 °C or 37 °C according to patients' comfort. 3. Expiratory positive end-expiratory pressure valve set to achieve PEEP=12 cmH2O. 4. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.

Treatment:

Device: Noninvasive respiratory support

High-flow nasal oxygen

Active Comparator group

Description:

Initial set flow will be 50-60 l/min and flows will be decreased. in case of intolerance and/or according to patients' requirements: flows≥30 L/min will be mandatory in all enrolled patients. Humidification chamber will be set at 31 °C, 34 °C or 37 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Weaning the patient from high-flow will be considered only after 48 hours from enrolment and will be discouraged until the patients is considered for ICU discharge.

Treatment:

Device: Noninvasive respiratory support