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Clinical Trials/NCT01915719
NCT01915719
Completed
N/A

Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.

Assistance Publique - Hôpitaux de Paris1 site in 1 country374 target enrollmentAugust 2013
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ConditionsAdultAcute Respiratory Failure Admitted in ICUImmuno Compromized

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adult
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
374
Locations
1
Primary Endpoint
Day 28 Mortality
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
February 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Day 28 Mortality

Time Frame: Day 28

Secondary Outcomes

  • Nosocomial infection(day 28)
  • Length of stay in ICU(Day 28)
  • Needs of mechanical ventilation(Day 28)
  • SOFA Score(Hour 72)
  • performance status (OMS scale ranging from 0-perfect status- to 4-moribund)(6 Months)

Study Sites (1)

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