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

NCT ID: NCT00202098

Last Updated: 2015-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome.

Detailed Description

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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.

Conditions

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ARDS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

ALI/ARDS patients

Group Type EXPERIMENTAL

Variable ventilation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Davide Chiumello

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Taccone, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Hospital Milan

Locations

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Policlinico Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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11

Identifier Type: -

Identifier Source: org_study_id

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