Status:
TERMINATED
Flow-flow ECCO2-R and 4 ml/kg Tidal Volume vs. 6 ml/kg Tidal Volume to Enhance Protection From VILI in Acute Lung Injury
Lead Sponsor:
University of Turin, Italy
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this randomized multicenter clinical trial is to test the hypothesis that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as compared to the c...
Detailed Description
The trial will test the hypothesis that a VT of 4 ml/kg PBW combined with low flow CO2 removal improves outcome in patients with severe ARDS (PFs ≤ 200 and PEEP ≥ 10) compared to ventilation with a VT...
Eligibility Criteria
Inclusion
- age \> 18 years
- are on invasive assisted breathing less then 48 hours
- less than 24 hours since diagnosis for ARDS: with PF\<=200 and PEEP\>=10, bilateral infiltrate on chest X-Ray and no clinical evidence of left atrial hypertension
- have a commitment to full support
Exclusion
- intubation and mechanical ventilation (any form) for \> 48 hours
- risk of systemic bleeding with anticoagulation
- acute brain injury
- body mass index \> 40
- neuromuscular disease that impairs ability to ventilate without assistance
- severe chronic respiratory disease
- burns \> 40% total body surface area
- malignancy or other irreversible disease or condition for which 6- month mortality is estimated to be greater than 50%
- allogeneic bone marrow transplant within the last 5 years
- chronic respiratory condition making patient respirator dependent
- patient, surrogate, or physician not committed to full support
- acute myocardial infarction or acute coronary syndrome within 30 days
- moribund patient: not expected to survive 24 hours
- no consent/inability to obtain consent
- patients receiving high frequency ventilation
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT01522599
Start Date
April 1 2012
End Date
January 1 2014
Last Update
June 17 2014
Active Locations (1)
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1
University of Turin - Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126