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Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. (IVNICTUS)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Adult
Acute Respiratory Failure Admitted in ICU
Immuno Compromized

Treatments

Procedure: Oxygen therapy only
Procedure: Early non invasive ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01915719
IVNICTUS

Details and patient eligibility

About

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

Enrollment

374 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

374 participants in 2 patient groups

Early non invasive ventilation
Experimental group
Description:
Early non invasive ventilation
Treatment:
Procedure: Early non invasive ventilation
Oxygen therapy only
Active Comparator group
Description:
Oxygen therapy only
Treatment:
Procedure: Oxygen therapy only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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