Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465309
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : January 12, 2009
Regione Piemonte
Information provided by:
University of Turin, Italy

April 24, 2007
April 25, 2007
January 12, 2009
April 2007
Not Provided
pulmonary inflammatory mediator reduction [ Time Frame: within the first 72 hours after enrollment ]
pulmonary inflammatory mediator reduction
Complete list of historical versions of study NCT00465309 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
Not Provided

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.

Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and consequently Pplat to obtain a Stress Index value equal to 1.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Adult Respiratory Distress Syndrome
Procedure: protective ventilation with CO2 removal technique
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.
Not Provided
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. Epub 2006 Oct 12.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
November 2008
Not Provided

Inclusion Criteria:

  • ARDS patients with Pplat >= 26 during NIH protective ventilation protocol

Exclusion Criteria:

  • 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
  • Burns BSA>30%
  • Hepatic failure (grade C Child)
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Marco Ranieri, University of Turin, Italy
University of Turin, Italy
Regione Piemonte
Study Director: V. M. Ranieri, MD University of Turin, Italy
Principal Investigator: P. Terragni, MD University of Turin, Italy
University of Turin, Italy
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP