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

NCT01373905 — Not applicable, Completed, 24 participants, University of Alexandria

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Stepwise PEEP Elevation With Determination of the Alveolar Collapsing Pressure Versus Sustained Lung Inflation as a Recruitment Maneuver in Patients With ARDS

Registry	NCT01373905
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	University of Alexandria (Other)
Conditions	Acute Respiratory Distress Syndrome
Interventions	Recruitment maneuver, recruitment maneuver (Procedure)
Dates	start 2007-01-01, primary completion 2008-02-01, completion 2008-02-01, first posted 2011-06-15, last updated 2011-06-15
Locations	1 site in Egypt

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Sustained lung inflation	Active comparator	Procedure: Recruitment maneuver	recruitment was done using CPAP of 30 Cm/ H2o for 30 seconds
Stepwise PEEP elevation	Active comparator	Procedure: Recruitment maneuver	Recruitment was done using stepwise elevation of PEEP followed by determination of the alveolar collapsing pressure

Recruitment maneuver (Procedure): group I: Recruitment by CPAP 30 cm/H2o for 30 seconds group II: Using pressure controlled ventilation with end-inspiratory minus end-expiratory pressure of 15 cmH2O, respiratory rate of 10-15 C / min. PEEP was increased by 5 cm/ H2O every 2 minutes till Maximum of 40 cmH2O, patient was considered recruited if PaO2 of 250 mmHg was achieved. Then progressive decreases of PEEP in steps of 2 cmH2O every 2 minutes till PaO2 dropped by a 10% or more (alveolar collapsing pressure)
recruitment maneuver (Procedure): recruitment as done by CPAP 30 cm/ H2o for 30 seconds or by stepwise elevation of PEEP by 5 cm/ H20 till 40 Cm/ H2o

+Outcome measures

Primary outcomes

All cause mortality [30 days]

Secondary outcomes

Efficacy [24 hours]: oxygenation index, compliance and lung infiltration

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine	Alexandria, Alexandria Governorate	Egypt

+Publications

Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11. PMID 16690982

+Investigators

Ahmed M El-Mehalawy, MD, Principal investigator, Faculty of Medicine, Alexandria University, Egypt