Hypoxemic Respiratory Failure, Respiratory Failure
Conditions
Keywords
Noninvasive ventilation, High-flow nasal oxygen, Mechanical ventilation
Brief summary
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
Treatment of acute hypoxemic respiratory failure
Sponsors
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Catholic University of the Sacred Heart
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Endotracheal intubation | 28 days | The proportion of patients requiring endotracheal intubation according to predefined criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days free of invasive mechanical ventilation at day 60 | 60 days | The number of days in which patients do not receive mechanical ventilation within 60 days from randomization |
| Days free of invasive mechanical ventilation at day 90 | 90 days | The number of days in which patients do not receive mechanical ventilation within 60 days from randomization |
| Rate of In-intensive care unit mortality | 90 days | All-cause mortality, assessed at the discharge from the intensive care unit |
| Rate of In-hospital care unit mortality | 90 days | All-cause mortality, assessed at the discharge from the hospital |
| Rate of 90-day mortality | 90 days | All-cause 90-day mortality |
| 90-day ICU free days | 90 days | The days not spent in the intensive care unit by the patient on a 90-day basis |
| 90-day hospital free days | 90 days | The days not spent in the hospital by the patient on a 90-day basis |
| Incidence of pneumonia | 90 days | Incidence of pneumonia, diagnosed after the treatment start and during the ICU stay |
| Incidence of shock | 90 days | Incidence of shock, diagnosed after treatment start and during the ICU stay |
| Incidence of barotrauma | 90 days | Incidence of barotrauma, defined as pneumothorax o pneumomediastinum after treatment start and during the ICU stay |
| Days free of invasive mechanical ventilation at day 28 | 28 days | The number of days in which patients do not receive mechanical ventilation within 28 days from randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint-causes of endotracheal intubation | 28 days | Among patients meeting the primary endpoint, the cause of noninvasive treatment failure (as defined by the predefined intubation criteria) |
| Safety endpoint-time to treatment failure | 28 days | In patients meeting the primary endpoint, the time (hours) from randomization to intubation |
Countries
Italy
Contacts
Primary ContactDomenico Luca Grieco, MD
Outcome results
None listed