Acute Hypoxemic Respiratory Failure
Conditions
Keywords
respiratory failure
Brief summary
Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.
Interventions
DEVICENon-invasive ventilation
Noninvasive ventilation: The inspiratory(IPAP) and expiratory positive airways pressure (EPAP), and the levels of FiO2 is set achieve SpO2 \>92% or PaO2 \>65 mmHg.
DEVICEHigh flow nasal cannula system
High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 \>92% or PaO2 \>65 mmHg.
Sponsors
Asan Medical Center
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
* Age above 18 * patients with acute hypoxemic respiratory failure
Exclusion criteria
* age \< 18 years * hypercapnia (arterial carbon dioxide tension (PaCO2) \>45mmHg) at admission * need for emergency intubation, including cardiopulmonary resuscitation * recent esophageal, facial or cranial trauma or surgery * severely decreased consciousness (Glasgow coma score \<11) * cardiogenic shock or severe hemodynamic instability * systolic blood pressure \<90 mmHg associated with decreased urinary output(\<20 mL.h-1) despite fluid repletion and use of vasoactive agents * lack of co-operation * altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures * tracheotomy or other upper airway disorders * severe ventricular arrhythmia or active myocardial ischemia * active upper gastrointestinal bleeding * inability to clear respiratory secretions * more than one severe organ dysfunction in addition to respiratory failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of treatment in two groups | up to 28 days | Successful treatment is to avoid intubation and achieve PaO2 \>75 mmHg without respiratory distress for 24 hours while spontaneously breathing oxygen provided by a Venturi device at FiO2 0.50. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compliance of treatment | up to 28 days | Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance |
| adverse event | up to 28 days | — |
| hospital length of stay | up to 90 days | — |
| Hospital mortality | up to 90 days | — |
Countries
South Korea
Outcome results
None listed