Status:
COMPLETED
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Adult
Acute Respiratory Failure Admitted in ICU
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT01915719
Start Date
August 1 2013
End Date
February 1 2016
Last Update
April 18 2016
Active Locations (1)
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1
APHP, Hôpital Saint Louis
Paris, France, 75010