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

Not Applicable

Completed

• Conditions: Adult; Acute Respiratory Failure Admitted in ICU; Immuno Compromized
• Interventions: Procedure: Oxygen therapy only; Procedure: Early non invasive ventilation

• Registration Number: NCT01915719
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-26
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Primary Completion: 2015-08
• Status Verified: 2015-11
• Study Completion: 2016-02
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen therapy only	Oxygen therapy only	Oxygen therapy only
Early non invasive ventilation	Early non invasive ventilation	Early non invasive ventilation

Primary Outcome Measures

Name	Time	Method
Day 28 Mortality	Day 28

Secondary Outcome Measures

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

Trial Locations

Locations (1)

APHP, Hôpital Saint Louis; 🇫🇷 Paris, France