Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure
- Conditions
- Respiratory Failure With Hypoxia
- Interventions
- Device: Noninvasive respiratory support
- Registration Number
- NCT04502576
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2<=200 mmHg) PaCO2<45 mmHg pH>7.30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-flow nasal cannula Noninvasive respiratory support 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. Helmet noninvasive ventilation Noninvasive respiratory support 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.
- Primary Outcome Measures
Name Time Method Respiratory-support free days within 28 days from randomization 28 days The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)
- Secondary Outcome Measures
Name Time Method In-intensive care unit mortality 90 days Clinical outcome (dead/alive) at intensive care unit discharge
Quality of life after recovery 1 year Quality of life in survivors, assessed by Short Form-36 questionnaire
Respiratory rate 28 days Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
In-hospital mortality 90 days Clinical outcome (dead/alive) at hospital discharge
Invasive ventilation-free days within 60 days from randomization 60 days The number of days in which patients did not receive invasive mechanical ventilation
Oxygenation 28 days The ratio of PaO2 to FiO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Dyspnea 28 days Dyspnea will be evaluated through a visual analog scale (0-10, where 10 represents the most sever symptom) will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Endotracheal intubation 28 days The proportion of patients requiring endotracheal intubation in the two groups. The need for endotracheal intubation will be established with predefined criteria, which will be evaluated a posteriori by an independent adjudication committee
Invasive ventilation-free days within 28 days from randomization 28 days The number of days in which patients did not receive invasive mechanical ventilation
Carbon dioxide 28 days PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
90-day mortality 90 days Clinical outcome (dead/alive) at 90 days after randomization
Trial Locations
- Locations (5)
SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
🇮🇹Chieti, Italy
Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
🇮🇹Ferrara, Italy
Fondazione Policlinico Universitaro A. Gemelli IRCCS
🇮🇹Rome, Italy
Infermi Hospital
🇮🇹Rimini, Italy