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

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

This study is currently recruiting participants.

Study NCT00188058. Last updated on September 12, 2005. Information provided by University Hospital, Angers

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).

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 strategies for setting end-expiratory pressure.

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 oxygenation. While the beneficial effect on clinical outcome of using low tidal volume is clearly proven, the best way to titrate PEEP is not known. Higher PEEP levels may better improve oxygenation and reduce ventilator-induced lung injury by reducing end-expiratory alveolar collapse but may also cause circulatory depression and aggravate lung injury from end-inspiratory overdistension. This trial compares the impact on outcome of two strategies for setting PEEP. In the "minimal alveolar distension" arm, PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H20). In the "maximal alveolar recruitment" arm, PEEP is set for a plateau pressure between 28 and 30 cm H20. A tidal volume of 6 ml/kg predicted body weight is used in the two arms. The goals for arterial oxygenation and PaCO2 are the same in the two arms.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Mortality at 28 days

Secondary Outcome Measure ^†

Mortality at 60 days
In hospital mortality
Ventilator free Days through day 28
Number of new organ failure before day 28
Proportion of patients alive and unassisted breathing at 28 days
Number of patients with pneumothorax
Number of days alive between the first positive "potential weanability test" and day 28

Condition ^†

Acute Respiratory Distress Syndrome
Acute Lung Injury

Intervention ^†

Device: Setting of positive end-expiratory pressure

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

800

Start Date ^†

September 2002

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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 Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: ALAIN MERCAT, MD

(0)2–41–35–38–15 ext 33

AlMercat@chu-angers.fr

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00188058

Organization ID

PHRC 01 - 02

Secondary IDs ^††

DGS : 2002 - 0381

Study Sponsor ^†

University Hospital, Angers

Collaborators ^††

Ministry of Health, France

Investigators ^†

Principal Investigator:

ALAIN MERCAT, MD

University Hospital of Angers

Information Provided By

University Hospital, Angers

Verification Date

September 2005

First Received Date ^†

September 12, 2005

Last Updated Date

September 12, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.