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Completed

NCT Number: NCT00786292

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

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.

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Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Carl Gustav Carus, Technical University Dresden

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assisted mechanical ventilation

Other

Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

Primary outcomes

  1. Effect on the arterial oxygenation

Secondary outcomes

  1. Effect on the work of breathing

  2. Effect on PaCO2

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Acronym: EVA

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2008
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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