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

Acute Respiratory Distress Syndrome Clinical Trial

— ExPress  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188058
• Other study ID #: PHRC 01 - 02
• Secondary ID: DGS : 2002 - 038
• Status: Completed
• Phase: N/A
• Start date: September 2002
• Est. completion date: February 2006

Study information

• Verified date: March 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• Setting of positive end-expiratory pressure

Locations

Country	Name	City	State
France	General Hospital of Aix en Provence	Aix en Provence
France	South Hospital of Amiens	Amiens
France	University Hospital of Amiens	Amiens
France	University Hospital of Angers	Angers
France	University Hospital of Angers	Angers
France	Victor Dupouy Hospital	Argenteuil
France	General Hospital of Arras	Arras
France	Robert Ballanger Hospital	Aulnay Sous Bois
France	General Hospital of Avignon	Avignon
France	Hospital of Beauvais	Beauvais
France	Saint André Hospital	Bordeaux
France	University Hospital of Bordeaux	Bordeaux
France	Cavale Blanche Hospital	Brest
France	Hospital of Brive	Brive
France	Henri Mondor Hospital	Creteil
France	Henri Mondor Hospital	Créteil
France	Hospital of Dax	Dax
France	Hospital of Dieppe	Dieppe
France	Departemental Hospital	La Roche Sur Yon
France	Jacques Monod Hospital	Le Havre
France	Le Kremlin Bicetre Hospital	Le Kremlin Bicetre
France	Docteur Schaffner Hospital	Lens
France	University Hospital of Claude Huriez	Lille
France	Croix Rousse Hospital	Lyon
France	Bon Secours Hospital	Metz
France	Saint Eloi Hospital	Montpellier
France	Hospital of Nancy	Nancy
France	University Hospital of Hotel Dieu	Nantes
France	University Hospital of Nimes	Nimes
France	University Hospital of Nimes	Nimes
France	Oloron Sainte Marie Hospital	Oloron Sainte Marie
France	Regional Hospital of Orleans	Orleans
France	Bichat Claude Bernard Hospital	Paris
France	European Hospital of Georges Pompidou	Paris
France	Hospital Group of Pitié - Salpêtrière	Paris
France	Hospital group of Pitié-Salpêtrière	Paris
France	University Hospital of Hôtel Dieu	Paris
France	University Hospital of Jean Bernard	Poitiers
France	University Hospital of La Milètrie	Poitiers
France	René Dubos Hospital	Pontoise
France	Charles Nicolle Hospital	Rouen
France	University Hospital of Rouen	Rouen
France	Saint Aubin Les Elbeuf Hospital	Saint Aubin Les Elbeuf
France	University Hospital of Bellevue	Saint-etienne
France	Hospital of Soissons	Soissons
France	Hautepierre Hospital	Strasbourg
France	Gustave Dron Hospital	Tourcoing

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 28 days		day 28
Secondary	Mortality at 60 days		day 60
Secondary	In hospital mortality		day 60
Secondary	Ventilator free Days through day 28		day 28
Secondary	Number of new organ failure before day 28		day 28
Secondary	Proportion of patients alive and unassisted breathing at 28 days		day 28
Secondary	Number of patients with pneumothorax		day 28
Secondary	Number of days alive between the first positive "potential weanability test" and day 28		day 28