Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
EVA
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2008
CompletedFirst Posted
Study publicly available on registry
November 6, 2008
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 5, 2012
July 1, 2009
3.2 years
November 5, 2008
September 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Effect on the arterial oxygenation
Secondary Outcomes (2)
Effect on the work of breathing
Effect on PaCO2
Study Arms (2)
Noisy PSV
OTHERAssisted mechanical ventilation with noisy PSV
PSV
OTHERAssisted mechanical ventilation with PSV
Interventions
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
Eligibility Criteria
You may qualify if:
- age 18 to 75 yrs
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic Carl Gustav Carus, Technical University Dresden
Dresden, 01307, Germany
Related Publications (1)
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.
PMID: 24172538DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo Gama de Abreu, MD, PhD
Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
July 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 5, 2012
Record last verified: 2009-07