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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
  Purpose

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.


Condition Intervention
Acute Lung Injury
 Other: Assisted mechanical ventilation

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • Effect on the arterial oxygenation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on the work of breathing [ Designated as safety issue: No ]
  • Effect on PaCO2 [ Designated as safety issue: No ]

Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Noisy PSV
Assisted mechanical ventilation with noisy PSV
 Other: Assisted mechanical ventilation
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
PSV
Assisted mechanical ventilation with PSV
 Other: Assisted mechanical ventilation
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786292

Locations
Germany
University Clinic Carl Gustav Carus, Technical University Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
  More Information

No publications provided

Responsible Party: PD Dr. Marcelo Gama de Abreu, Prof. Dr., Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00786292     History of Changes
Other Study ID Numbers: EK276112007
Study First Received: November 5, 2008
Last Updated: September 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013