Stepwise Positive End Expiratory Pressure Elevation For Lung Recruitment in Acute Respiratory Distress Syndrome (ARDS)
Stepwise PEEP Elevation With Determination of the Alveolar Collapsing Pressure Versus Sustained Lung Inflation as a Recruitment Maneuver in Patients With ARDS
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedJune 15, 2011
February 1, 2008
1.1 years
June 8, 2011
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
30 days
Secondary Outcomes (1)
Efficacy
24 hours
Study Arms (2)
Sustained lung inflation
ACTIVE COMPARATORrecruitment was done using CPAP of 30 Cm/ H2o for 30 seconds
Stepwise PEEP elevation
ACTIVE COMPARATORRecruitment was done using stepwise elevation of PEEP followed by determination of the alveolar collapsing pressure
Interventions
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)
Eligibility Criteria
You may qualify if:
- ARDS
- lung injury score more than 2.5
- on mechanical ventilation
You may not qualify if:
- hemodynamic instability
- left heart failure
- pneumothorax
- COPD
- restrictive lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Alexandria, Alexandria Governorate, Egypt
Related Publications (1)
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: 16690982BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M El-Mehalawy, MD
Faculty of Medicine, Alexandria University, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 15, 2011
Study Start
January 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 15, 2011
Record last verified: 2008-02