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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lung Injury
• Intervention / Treatment: Other: Assisted mechanical ventilation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • University Clinic Carl Gustav Carus, Technical University Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: PSV; Assisted mechanical ventilation with PSV	Other: Assisted mechanical ventilation; Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect on the arterial oxygenation

Secondary Outcome Measures

Outcome Measure
Effect on the work of breathing
Effect on PaCO2

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Marcelo Gama de Abreu, MD, PhD, Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden

Publications and helpful links

General Publications

• Spieth PM, Guldner A, Huhle R, Beda A, Bluth T, Schreiter D, Ragaller M, Gottschlich B, Kiss T, Jaber S, Pelosi P, Koch T, Gama de Abreu M. Short-term effects of noisy pressure support ventilation in patients with acute hypoxemic respiratory failure. Crit Care. 2013 Oct 31;17(5):R261. doi: 10.1186/cc13091.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 5, 2008
• First Submitted That Met QC Criteria: November 5, 2008
• First Posted (Estimate): November 6, 2008

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 3, 2012
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: EK276112007