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CompletedNCT01373905Updated Jun 15, 2011

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

An interventional study of Recruitment maneuver and recruitment maneuver in Acute Respiratory Distress Syndrome, sponsored by University of Alexandria. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-15.

Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • ARDS
  • PEEP
  • Recruitment maneuver
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University of Alexandria is the lead sponsor of 57 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Sustained lung inflation

    recruitment was done using CPAP of 30 Cm/ H2o for 30 seconds

    Procedure: Recruitment maneuver

  • Active comparator
    Stepwise PEEP elevation

    Recruitment was done using stepwise elevation of PEEP followed by determination of the alveolar collapsing pressure

    Procedure: Recruitment maneuver

Interventions

  • ProcedureRecruitment maneuver

    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)

  • Procedurerecruitment maneuver

    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

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What researchers measure

Primary outcomes

  1. All cause mortality

    Time frame: 30 days

Secondary outcomes

  1. Efficacy

    oxygenation index, compliance and lung infiltration

    Time frame: 24 hours

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Study locations

1 site
  • Faculty of Medicine
    Alexandria, Egypt
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References and documents

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. PubMed 16690982 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01373905
Lead sponsor
University of Alexandria
First posted
Jun 15, 2011
Start date
Jan 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Jun 15, 2011

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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