Respiratory Failure With Hypoxia
Conditions
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.
Interventions
In both arms, 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. Patients will have to undergo the allocated treatment within 1 hour from the moment of randomization and within 24 hours from admission in the intensive care unit
Sponsors
Università degli studi di Chieti
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Invasive ventilation-free days within 28 days from randomization | 28 days | The number of days in which patients did not receive invasive mechanical ventilation |
| 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 |
| 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 |
| 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 |
| In-intensive care unit mortality | 90 days | Clinical outcome (dead/alive) at intensive care unit discharge |
| In-hospital mortality | 90 days | Clinical outcome (dead/alive) at hospital discharge |
| 90-day mortality | 90 days | Clinical outcome (dead/alive) at 90 days after randomization |
| 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 |
Countries
Italy
Outcome results
None listed