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

April 15, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • APHP, Hôpital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early non invasive ventilation
Procedure: Early non invasive ventilation
Active Comparator: Oxygen therapy only
Procedure: Oxygen therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Day 28 Mortality
Time Frame: Day 28
Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVNICTUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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