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

This study has been completed.
Sponsor:
Information provided by:
Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:
NCT01373905
First received: June 8, 2011
Last updated: June 14, 2011
Last verified: February 2008
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome
Procedure: Recruitment maneuver
Procedure: recruitment maneuver

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stepwise PEEP Elevation With Determination of the Alveolar Collapsing Pressure Versus Sustained Lung Inflation as a Recruitment Maneuver in Patients With ARDS

Further study details as provided by Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    oxygenation index, compliance and lung infiltration


Enrollment: 24
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sustained lung inflation
recruitment was done using CPAP of 30 Cm/ H2o for 30 seconds
Procedure: Recruitment 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)
Procedure: recruitment 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
Active Comparator: Stepwise PEEP elevation
Recruitment was done using stepwise elevation of PEEP followed by determination of the alveolar collapsing pressure
Procedure: Recruitment 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)
Procedure: recruitment 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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373905

Locations
Egypt
Faculty of Medicine
Alexandria, Egypt
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
Investigators
Principal Investigator: Ahmed M El-Mehalawy, MD Faculty of Medicine, Alexandria University, Egypt
  More Information

Publications:
Responsible Party: Vice-Dean for Post-Graduate Studies and Research, faculty of Medicine - university of Alexandria
ClinicalTrials.gov Identifier: NCT01373905     History of Changes
Other Study ID Numbers: Faculty of Medicine12.12.2006
Study First Received: June 8, 2011
Last Updated: June 14, 2011
Health Authority: Egtpt:University of Alexandria Post-graduate studies and Research comittee

Keywords provided by Faculty of Medicine, University of Alexandria:
ARDS
PEEP
Recruitment maneuver

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 22, 2014