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

January 9, 2009 updated by: University of Turin, Italy

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.

Study Overview

Status

Completed

Conditions

Adult Respiratory Distress Syndrome

Intervention / Treatment

Procedure: protective ventilation with CO2 removal technique

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

Enrollment (Anticipated)

200

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Turin, Italy, 10126
    - 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pulmonary inflammatory mediator reduction Time Frame: within the first 72 hours after enrollment	within the first 72 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Collaborators

Regione Piemonte

Investigators

Study Director: V. M. Ranieri, MD, University of Turin, Italy
Principal Investigator: P. Terragni, MD, University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 24, 2007

First Submitted That Met QC Criteria