Stepwise Positive End Expiratory Pressure Elevation For Lung Recruitment in Acute Respiratory Distress Syndrome (ARDS)

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: recruitment maneuver

• Registration Number: NCT01373905
• Lead Sponsor: University of Alexandria

Brief Summary

Acute respiratory distress syndrome is a severe lung disease caused by a variety of direct and indirect issues. It is characterized by inflammation of the lung parenchyma leading to impaired gas exchange and persistent hypoxemia. This condition is often fatal, usually requiring mechanical ventilation. Recruitment maneuver aimed to enhance the effect of mechanical ventilation.The objective of this study was to compare safety and efficacy of two lung recruitment maneuvers.

Detailed Description

In patients with acute respiratory distress syndrome (ARDS), protective lung strategy and positive end expiratory pressure (PEEP) therapy should be started as early as possible to avoid lung damage by high pressures, volumes and fraction of inspired oxygen (FiO2). Recruitment is a strategy aiming at re-expanding the collapsed lung tissue and then maintaining an adequate level of PEEP to prevent subsequent de-recruitment. The objective of this study was to compare safety and efficacy of two lung recruitment maneuvers (RM): stepwise PEEP elevation with determination of the alveolar collapsing pressure versus sustained lung inflation in ARDS patients

Study Timeline

• Study Start: 2007-01
• Status Verified: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-14
• Last Update Submitted: 2011-06-14
• Study First Posted: 2011-06-15
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• ARDS
• lung injury score more than 2.5
• on mechanical ventilation

Exclusion Criteria

• hemodynamic instability
• left heart failure
• pneumothorax
• COPD
• restrictive lung disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained lung inflation	recruitment maneuver	recruitment was done using CPAP of 30 Cm/ H2o for 30 seconds
Stepwise PEEP elevation	recruitment maneuver	Recruitment was done using stepwise elevation of PEEP followed by determination of the alveolar collapsing pressure

Primary Outcome Measures

Name	Time	Method
All cause mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Efficacy	24 hours	oxygenation index, compliance and lung infiltration

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt