Status:

COMPLETED

Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Lead Sponsor:

University Hospital, Angers

Collaborating Sponsors:

Ministry of Health, France

Conditions:

Acute Respiratory Distress Syndrome

Acute Lung Injury

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two st...

Detailed Description

Most patients suffering from acute lung injury or acute respiratory distress syndrome require mechanical ventilation. In this setting, positive end-expiratory pressure is used to improve arterial oxyg...

Eligibility Criteria

Inclusion

  • Mechanical ventilation through an endotracheal tube
  • Bilateral infiltrates consistent with pulmonary edema
  • PaO2/FiO2 \< 300 mmHg
  • No clinical evidence of left atrial hypertension. If measured, pulmonary artery occlusion pressure \< 18 mmHg
  • Criteria 1, 2 et 3 jointly present for less than 48 hours
  • Written informed consent obtained from the patient or surrogate

Exclusion

  • Age \< 18 years
  • Pregnancy
  • Expected duration of mechanical ventilation through an endotracheal tube \< 48 hours
  • Participation in other trials within the previous 30 days
  • Increased intracranial pressure
  • Severe chronic respiratory disease
  • Morbid obesity (weight \> 1kg/cm)
  • Sickle cell disease
  • Bone marrow transplant or chemotherapy-induced neutropenia
  • Extended burns (\> 30 % total body surface area)
  • Severe chronic liver disease (Child-Pugh score C)
  • Pneumothorax

Key Trial Info

Start Date :

September 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2006

Estimated Enrollment :

768 Patients enrolled

Trial Details

Trial ID

NCT00188058

Start Date

September 1 2002

End Date

February 1 2006

Last Update

March 22 2019

Active Locations (46)

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Page 1 of 12 (46 locations)

1

General Hospital of Aix en Provence

Aix-en-Provence, France, 13616

2

South Hospital of Amiens

Amiens, France, 80054

3

University Hospital of Amiens

Amiens, France, 80054

4

University Hospital of Angers

Angers, France, 49033

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