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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00202098
First received: September 12, 2005
Last updated: November 13, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 Policlinico Hospital:

Primary Outcome Measures:
  • Gas exchange and respiratory mechanics [ Time Frame: within the first 60 minutes from the ventilatory change ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2005
Estimated Study Completion Date: December 2014
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202098

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

No publications provided

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00202098     History of Changes
Other Study ID Numbers: 11
Study First Received: September 12, 2005
Last Updated: November 13, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
ARDS
mechanical ventilation
variable ventilation
chaotic ventilation

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Respiratory System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014