Acute Respiratory Failure Admitted in ICU, Adult, Immuno Compromized
Conditions
Brief summary
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
Interventions
PROCEDUREEarly non invasive ventilation
PROCEDUREOxygen therapy only
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age over 18 years old * ICU admission * Acute respiratory failure defined by (PaO2\<60 mmHg at room air) or (polypnea \>30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours. * Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid \> 1mg/kg/d or \>1 month or other immunosuppressive treatment \>1 month)
Exclusion criteria
* Hypercapnia \>50 mmHg or increased of hypercapnia \>10 mmHg under Oxygen treatment * Need of immediate mechanical ventilation * Obvious cardiogenic oedema * Vasopressor use \>0.03 µg/kg/min * Glasgow Score \<13 * End of life decision * Acute myocardial infarction * Patient refusal * Pregnancy * No national health insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 28 Mortality | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Needs of mechanical ventilation | Day 28 |
| SOFA Score | Hour 72 |
| Nosocomial infection | day 28 |
| Length of stay in ICU | Day 28 |
| performance status (OMS scale ranging from 0-perfect status- to 4-moribund) | 6 Months |
Countries
France
Outcome results
None listed