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OpenTrials
Completed

NCT Number: NCT01915719

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

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

Completed

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Key information

Conditions

Adult Acute Respiratory Failure Admitted in ICU Immuno Compromized

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APHP, Hôpital Saint Louis

Paris, 75010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early non invasive ventilation

Procedure

Oxygen therapy only

Procedure

Primary outcomes

  1. Day 28 Mortality

    Time frame: Day 28

Secondary outcomes

  1. Needs of mechanical ventilation

    Time frame: Day 28

  2. SOFA Score

    Time frame: Hour 72

  3. Nosocomial infection

    Time frame: day 28

  4. Length of stay in ICU

    Time frame: Day 28

  5. performance status (OMS scale ranging from 0-perfect status- to 4-moribund)

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: IVNICTUS

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 5, 2013
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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