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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01915719
First received: July 26, 2013
Last updated: April 15, 2016
Last verified: November 2015
July 26, 2013
April 15, 2016
August 2013
August 2015   (Final data collection date for primary outcome measure)
Day 28 Mortality [ Time Frame: Day 28 ]
Same as current
Complete list of historical versions of study NCT01915719 on ClinicalTrials.gov Archive Site
  • Needs of mechanical ventilation [ Time Frame: Day 28 ]
  • SOFA Score [ Time Frame: Hour 72 ]
  • Nosocomial infection [ Time Frame: day 28 ]
  • Length of stay in ICU [ Time Frame: Day 28 ]
  • performance status (OMS scale ranging from 0-perfect status- to 4-moribund) [ Time Frame: 6 Months ]
Same as current
Not Provided
Not Provided
 
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adult
  • Acute Respiratory Failure Admitted in ICU
  • Immuno Compromized
  • Procedure: Early non invasive ventilation
  • Procedure: Oxygen therapy only
  • Experimental: Early non invasive ventilation
    Early non invasive ventilation
    Intervention: Procedure: Early non invasive ventilation
  • Active Comparator: Oxygen therapy only
    Oxygen therapy only
    Intervention: Procedure: Oxygen therapy only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
February 2016
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01915719
IVNICTUS
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Virginie lemiale, MD APHP
Assistance Publique - Hôpitaux de Paris
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP