search
Back to results

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

Primary Purpose

Adult Respiratory Distress Syndrome

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
protective ventilation with CO2 removal technique
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Respiratory Distress Syndrome focused on measuring Respiratory Insufficiency, CO2 removal, protective ventilation, ARDS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital
  • University of Turin, Department of Anesthesia and Intensive Care Medicine

Outcomes

Primary Outcome Measures

pulmonary inflammatory mediator reduction

Secondary Outcome Measures

Full Information

First Posted
April 24, 2007
Last Updated
January 9, 2009
Sponsor
University of Turin, Italy
Collaborators
Regione Piemonte
search

1. Study Identification

Unique Protocol Identification Number
NCT00465309
Brief Title
Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turin, Italy
Collaborators
Regione Piemonte

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Respiratory Distress Syndrome
Keywords
Respiratory Insufficiency, CO2 removal, protective ventilation, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
protective ventilation with CO2 removal technique
Intervention Description
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 Measure Information:
Title
pulmonary inflammatory mediator reduction
Time Frame
within the first 72 hours after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. M. Ranieri, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
P. Terragni, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
University of Turin, Department of Anesthesia and Intensive Care Medicine
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17038660
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs