Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure (HENIVOTpilot)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Respiratory Failure With Hypoxia

Treatments: Device: Noninvasive respiratory support

Study type: Interventional

Funder types: Other

Identifiers

NCT04502576

4443

Details and patient eligibility

About

Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure.

As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established.

The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2<=200 mmHg) PaCO2<45 mmHg pH>7.30

Exclusion criteria

Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

High-flow nasal cannula

Active Comparator group

Description:

High-flow nasal cannula will be delivered with the Optiflow system. Initial set flow will be ≥ 50 /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 (MR860, Fisher and Paykel healthcare, New Zealand) will be set at 37 °C or 34 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. The treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge. Weaning from high-flow will be considered as standardized criteria are met.

Treatment:

Device: Noninvasive respiratory support

Helmet noninvasive ventilation

Experimental group

Description:

Patients will receive continuous helmet pressure support ventilation for at least 16 hours/day the first 2 calendar days. Continuous noninvasive ventilation without interruptions will be strongly encouraged in the first 24 hours of treatment. The ventilator will be set in pressure support mode. Use of continuous positive airway pressure by flow generators and Venturi systems instead of pressure support ventilation will be allowed in case of shortage of ventilators. Maintenance of positive end-expiratory pressure ≥ 8-10 during the treatment is mandatory. After weaning and during any interruption from noninvasive ventilation, patients will undergo low-flow or high-flow oxygen, according to the decision of the attending physician. The treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge.

Treatment:

Device: Noninvasive respiratory support