Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
1 other identifier
interventional
200
1 country
2
Brief Summary
30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index\>1) conditions of hyperinflation even with Plateau pressure (Pplat) \< 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation. In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2007
2 active sites
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
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 24, 2007
CompletedFirst Posted
Study publicly available on registry
April 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJanuary 12, 2009
January 1, 2009
April 24, 2007
January 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pulmonary inflammatory mediator reduction
within the first 72 hours after enrollment
Interventions
In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat \< 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH \> 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.
Eligibility Criteria
You may qualify if:
- ARDS patients with Pplat \>= 26 during NIH protective ventilation protocol
You may not qualify if:
- Age \< 18 years
- Brain injury and patients with intracranial pressure \> 20 mmHg
- Pregnancy
- Immunodepressed patients
- Patients already enrolled in other trials
- Renal replacement therapy
- BMI \> 40
- Contraindication anticoagulation treatment
- Morphological abnormalities of femoral veins
- NYHA III-IV
- Burns BSA\>30%
- Hepatic failure (grade C Child)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Turin, Italylead
- Regione Piemontecollaborator
Study Sites (2)
University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital
Turin, Turin, 10126, Italy
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, 10126, Italy
Related Publications (1)
Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
PMID: 17038660BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
V. M. Ranieri, MD
University of Turin, Italy
- PRINCIPAL INVESTIGATOR
P. Terragni, MD
University of Turin, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 24, 2007
First Posted
April 25, 2007
Study Start
April 1, 2007
Study Completion
November 1, 2008
Last Updated
January 12, 2009
Record last verified: 2009-01