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Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr. Marcelo Gama de Abreu, Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00786292
First received: November 5, 2008
Last updated: September 3, 2012
Last verified: July 2009
History of Changes

November 5, 2008
September 3, 2012
July 2009
September 2012   (final data collection date for primary outcome measure)
Effect on the arterial oxygenation [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786292 on ClinicalTrials.gov Archive Site
  • Effect on the work of breathing [ Designated as safety issue: No ]
  • Effect on PaCO2 [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)

Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.
Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
Acute Lung Injury
Other: Assisted mechanical ventilation
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
  • Noisy PSV
    Assisted mechanical ventilation with noisy PSV
    Intervention: Other: Assisted mechanical ventilation
  • PSV
    Assisted mechanical ventilation with PSV
    Intervention: Other: Assisted mechanical ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18 to 75 yrs
  • 150 mmHg < PaO2/FIO2 < 300 mmHg
  • mechanical ventilation with PSV or BIPAP
  • less than 15 days of mechanical ventilation
  • at least 20% of minute ventilation originated from spontaneous breathing

Exclusion Criteria:

  • BMI > 35
  • esophageal disease
  • neuromuscular disease
  • instable thorax
  • pneumothorax
  • head trauma
  • brain injury
  • increased intracranial pressure
  • agitation
  • increased need for vasoactive drugs
  • chronic lung disease
  • acute coronary disease
  • participation in another clinical trial within the last 4 weeks at enrollment

Interruption criteria:

  • acute change of mental status
  • SaO2 < 92%
  • pHa < 7.30
  • respiratory rate > 30 or < 6 /min
  • dyspnea
  • diaphragm/thorax antagonism
  • diaphoresis
  • abnormal use of respiratory muscles
  • increase of the heart rate above 120% of baseline or absolute value < 60 or > 130 /min
  • mean arterial pressure above 120% of baseline or absolute value < 70 or > 110 mmHg
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00786292
EK276112007
No
PD Dr. Marcelo Gama de Abreu, Dresden University of Technology
Dresden University of Technology
Not Provided
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
Dresden University of Technology
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP