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

Acute Lung Injury Clinical Trial

— EVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786292
• Other study ID #: EK276112007
• Status: Completed
• Phase: N/A
• First received: November 5, 2008
• Last updated: September 3, 2012
• Start date: July 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2009
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Intervention

Other:
• Assisted mechanical ventilation
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

Locations

Country	Name	City	State
Germany	University Clinic Carl Gustav Carus, Technical University Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on the arterial oxygenation			No
Secondary	Effect on the work of breathing			No
Secondary	Effect on PaCO2			No