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

NCT ID: NCT00188058

Last Updated: 2019-03-22

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

768 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome Acute Lung Injury

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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Minimal alveolar distension

PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O

Group Type ACTIVE_COMPARATOR

Setting of positive end-expiratory pressure

Intervention Type DEVICE

Maximal alveolar distension

PEEP is set for a plateau pressure between 28 and 30 cm H20

Group Type EXPERIMENTAL

Setting of positive end-expiratory pressure

Intervention Type DEVICE

Interventions

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Setting of positive end-expiratory pressure

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ALAIN MERCAT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Angers

Locations

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General Hospital of Aix en Provence

Aix-en-Provence, , France

Site Status

South Hospital of Amiens

Amiens, , France

Site Status

University Hospital of Amiens

Amiens, , France

Site Status

University Hospital of Angers

Angers, , France

Site Status

University Hospital of Angers

Angers, , France

Site Status

Victor Dupouy Hospital

Argenteuil, , France

Site Status

General Hospital of Arras

Arras, , France

Site Status

Robert Ballanger Hospital

Aulnay-sous-Bois, , France

Site Status

General Hospital of Avignon

Avignon, , France

Site Status

Hospital of Beauvais

Beauvais, , France

Site Status

Saint André Hospital

Bordeaux, , France

Site Status

University Hospital of Bordeaux

Bordeaux, , France

Site Status

Cavale Blanche Hospital

Brest, , France

Site Status

Hospital of Brive

Brivé, , France

Site Status

Henri Mondor Hospital

Créteil, , France

Site Status

Hospital of Dax

Dax, , France

Site Status

Hospital of Dieppe

Dieppe, , France

Site Status

Departemental Hospital

La Roche-sur-Yon, , France

Site Status

Jacques Monod Hospital

Le Havre, , France

Site Status

Le Kremlin Bicetre Hospital

Le Kremlin-Bicêtre, , France

Site Status

Docteur Schaffner Hospital

Lens, , France

Site Status

University Hospital of Claude Huriez

Lille, , France

Site Status

Croix Rousse Hospital

Lyon, , France

Site Status

Bon Secours Hospital

Metz, , France

Site Status

Saint Eloi Hospital

Montpellier, , France

Site Status

Hospital of Nancy

Nancy, , France

Site Status

University Hospital of Hotel Dieu

Nantes, , France

Site Status

University Hospital of Nimes

Nîmes, , France

Site Status

University Hospital of Nimes

Nîmes, , France

Site Status

Oloron Sainte Marie Hospital

Oloron-Sainte-Marie, , France

Site Status

Regional Hospital of Orleans

Orléans, , France

Site Status

Bichat Claude Bernard Hospital

Paris, , France

Site Status

University Hospital of Hôtel Dieu

Paris, , France

Site Status

Hospital Group of Pitié - Salpêtrière

Paris, , France

Site Status

Hospital group of Pitié-Salpêtrière

Paris, , France

Site Status

European Hospital of Georges Pompidou

Paris, , France

Site Status

University Hospital of Jean Bernard

Poitiers, , France

Site Status

University Hospital of La Milètrie

Poitiers, , France

Site Status

René Dubos Hospital

Pontoise, , France

Site Status

Charles Nicolle Hospital

Rouen, , France

Site Status

University Hospital of Rouen

Rouen, , France

Site Status

Saint Aubin Les Elbeuf Hospital

Saint-Aubin-lès-Elbeuf, , France

Site Status

University Hospital of Bellevue

Saint-Etienne, , France

Site Status

Hospital of Soissons

Soissons, , France

Site Status

Hautepierre Hospital

Strasbourg, , France

Site Status

Gustave Dron Hospital

Tourcoing, , France

Site Status

Countries

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France

References

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Mercat A, Richard J, Brochard L. Comparison of two strategies for setting Peep in ALI/ARDS : EsPress Study.Intensive care med, 19th ESICM Annual Congress - Barcelona, Spain, 2006 Sep, Oral presentation 0365

Reference Type RESULT

Diehl JL, Coolen N, Faisy C, Osman D, Prat G, Sebbane M, Nieszkowska A, Gervais C, Richard JC, Richecoeur J, Brochard L, Mercat A, Guerot E, Borgel D. Growth-arrest-specific 6 (GAS6) protein in ARDS patients: determination of plasma levels and influence of PEEP setting. Respir Care. 2013 Nov;58(11):1886-91. doi: 10.4187/respcare.02129. Epub 2013 Apr 9.

Reference Type DERIVED
PMID: 23571515 (View on PubMed)

Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.

Reference Type DERIVED
PMID: 18270353 (View on PubMed)

Other Identifiers

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DGS : 2002 - 0381

Identifier Type: -

Identifier Source: secondary_id

PHRC 01 - 02

Identifier Type: -

Identifier Source: org_study_id

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