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

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ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment Phase
Adult Respiratory Distress Syndrome Procedure: protective ventilation with CO2 removal technique Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2007
Study Completion Date : November 2008

Intervention Details:
    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.

Primary Outcome Measures :
  1. pulmonary inflammatory mediator reduction [ Time Frame: within the first 72 hours after enrollment ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465309

University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital
Turin, Italy, 10126
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
Sponsors and Collaborators
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

Responsible Party: Marco Ranieri, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT00465309     History of Changes
Other Study ID Numbers: PR60ANMA06
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009

Keywords provided by University of Turin, Italy:
Respiratory Insufficiency
CO2 removal
protective ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury