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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Adult Acute Respiratory Failure Admitted in ICU Immuno Compromized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early non invasive ventilation

Group Type EXPERIMENTAL

Early non invasive ventilation

Intervention Type PROCEDURE

Oxygen therapy only

Group Type ACTIVE_COMPARATOR

Oxygen therapy only

Intervention Type PROCEDURE

Interventions

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Early non invasive ventilation

Intervention Type PROCEDURE

Oxygen therapy only

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No