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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.
Sponsor:
Collaborator:
Regione Piemonte
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00465309
First received: April 24, 2007
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Adult Respiratory Distress Syndrome
 Procedure: protective ventilation with CO2 removal technique
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

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

Estimated Enrollment: 200
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • NYHA III-IV
  • Burns BSA>30%
  • Hepatic failure (grade C Child)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465309

Locations
Italy
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Regione Piemonte
Investigators
Study Director: V. M. Ranieri, MD University of Turin
Principal Investigator: P. Terragni, MD University of Turin
  More Information

Publications:

Responsible Party: Marco Ranieri, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT00465309     History of Changes
Other Study ID Numbers: PR60ANMA06
Study First Received: April 24, 2007
Last Updated: January 9, 2009
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013