Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/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:

NCT00267241

First received: December 19, 2005

Last updated: November 30, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2005

Last Updated Date

November 30, 2011

Start Date ^ICMJE

December 2005

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gas exchange and respiratory mechanics [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Respiratory mechanics
Gas Exchange

Change History

Complete list of historical versions of study NCT00267241 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients

Official Title ^ICMJE

Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients

Brief Summary

The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.

Detailed Description

ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Respiratory Distress Syndrome, Adult

Intervention ^ICMJE

Other: Mechanical Ventilation

Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)

Study Arm (s)

Experimental: 1

ALI/ARDS patients

Intervention: Other: Mechanical Ventilation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with ALI/ARDS

Exclusion Criteria:

COPD patients
Barotrauma
Hemodynamic instability
Age less than 18

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00267241

Other Study ID Numbers ^ICMJE

1600

Has Data Monitoring Committee

Responsible Party

Davide Chiumello, Policlinico Hospital

Study Sponsor ^ICMJE

Policlinico Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Davide Chiumello, MD

Policlinico Hospital

Information Provided By

Policlinico Hospital

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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