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Effects of Variable Ventilation on Respiratory System of Acute Respiratory Distress Syndrome (ARDS) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202098
First Posted: September 20, 2005
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
  Purpose
The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome.

Condition Intervention
ARDS Procedure: Variable ventilation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Variable Ventilation on Respiratory System of ARDS Patients

Resource links provided by NLM:


Further study details as provided by Davide Chiumello, Policlinico Hospital:

Primary Outcome Measures:
  • Gas exchange and respiratory mechanics [ Time Frame: within the first 60 minutes from the ventilatory change ]

Estimated Enrollment: 16
Study Start Date: March 2005
Study Completion Date: March 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ALI/ARDS patients
Procedure: Variable ventilation
Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period the investigators will record the gas exchange parameters and the mechanics of the respiratory system.

Detailed Description:

In this interventional study we want to evaluate the effect of Variable ventilation (1) in patients with ARDS. Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period we will record the gas exchange parameters and the mechanics of the respiratory system.

1. Arold S, Mora R, Lutchen K, et al. Variable ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Resp Crit Care Med 2000; 165: 366-71.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ARDS criteria

Exclusion Criteria:

  • Age less than 18 years
  • Severe haemodynamic instability
  • Patients with clinical or instrumental evidence of flow-limitation (i.e., PEEPi)
  Contacts and Locations
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): NCT00202098


Locations
Italy
Policlinico Hospital
Milan, Italy
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Paolo Taccone, MD Policlinico Hospital, milan
  More Information

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00202098     History of Changes
Other Study ID Numbers: 11
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Davide Chiumello, Policlinico Hospital:
ARDS
mechanical ventilation
variable ventilation
chaotic ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Lung Injury
Respiratory System Agents