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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
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 5, 2008
Last Updated
September 3, 2012
Sponsor
Technische Universität Dresden
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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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