Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA)
Primary Purpose
Acute Lung Injury
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Assisted mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury
Eligibility 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
Sites / Locations
- University Clinic Carl Gustav Carus, Technical University Dresden
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Noisy PSV
PSV
Arm Description
Assisted mechanical ventilation with noisy PSV
Assisted mechanical ventilation with PSV
Outcomes
Primary Outcome Measures
Effect on the arterial oxygenation
Secondary Outcome Measures
Effect on the work of breathing
Effect on PaCO2
Full Information
NCT ID
NCT00786292
First Posted
November 5, 2008
Last Updated
September 3, 2012
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00786292
Brief Title
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
Acronym
EVA
Official Title
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Noisy PSV
Arm Type
Other
Arm Description
Assisted mechanical ventilation with noisy PSV
Arm Title
PSV
Arm Type
Other
Arm Description
Assisted mechanical ventilation with PSV
Intervention Type
Other
Intervention Name(s)
Assisted mechanical ventilation
Intervention Description
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
Primary Outcome Measure Information:
Title
Effect on the arterial oxygenation
Secondary Outcome Measure Information:
Title
Effect on the work of breathing
Title
Effect on PaCO2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Gama de Abreu, MD, PhD
Organizational Affiliation
Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Carl Gustav Carus, Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24172538
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
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