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

This study has been completed.
Regione Piemonte
Information provided by:
University of Turin, Italy Identifier:
First received: April 24, 2007
Last updated: January 9, 2009
Last verified: January 2009

April 24, 2007
January 9, 2009
April 2007
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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
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Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
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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: 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.
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2008
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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, Senior)
Contact information is only displayed when the study is recruiting subjects
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Marco Ranieri, University of Turin, Italy
University of Turin, Italy
Regione Piemonte
Study Director: V. M. Ranieri, MD University of Turin
Principal Investigator: P. Terragni, MD University of Turin
University of Turin, Italy
January 2009

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