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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Recruitment maneuver
recruitment maneuver
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, PEEP, Recruitment maneuver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sustained lung inflation

Stepwise PEEP elevation

Arm Description

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

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

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Efficacy
oxygenation index, compliance and lung infiltration

Full Information

First Posted
June 8, 2011
Last Updated
June 14, 2011
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT01373905
Brief Title
Stepwise Positive End Expiratory Pressure Elevation For Lung Recruitment in Acute Respiratory Distress Syndrome (ARDS)
Official Title
Stepwise PEEP Elevation With Determination of the Alveolar Collapsing Pressure Versus Sustained Lung Inflation as a Recruitment Maneuver in Patients With ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alexandria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, PEEP, Recruitment maneuver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sustained lung inflation
Arm Type
Active Comparator
Arm Description
recruitment was done using CPAP of 30 Cm/ H2o for 30 seconds
Arm Title
Stepwise PEEP elevation
Arm Type
Active Comparator
Arm Description
Recruitment was done using stepwise elevation of PEEP followed by determination of the alveolar collapsing pressure
Intervention Type
Procedure
Intervention Name(s)
Recruitment maneuver
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
recruitment maneuver
Intervention Description
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
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Efficacy
Description
oxygenation index, compliance and lung infiltration
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M El-Mehalawy, MD
Organizational Affiliation
Faculty of Medicine, Alexandria University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16690982
Citation
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.
Results Reference
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Stepwise Positive End Expiratory Pressure Elevation For Lung Recruitment in Acute Respiratory Distress Syndrome (ARDS)

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