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

ARDS Clinical Trial

Official title:

Effects of Variable Ventilation on Respiratory System of ARDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202098
• Other study ID #: 11
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: March 18, 2015
• Start date: March 2005
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
Italy	Policlinico Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gas exchange and respiratory mechanics		within the first 60 minutes from the ventilatory change	No