The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients

This study has been completed.

First Received on August 31, 2005. Last Updated on November 30, 2011 History of Changes

Sponsor:	Policlinico Hospital
Information provided by (Responsible Party):	Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT00143468

Purpose

The investigators aim to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation.

Condition	Intervention
Acute Lung Injury ARDS	Behavioral: mechanical ventilation

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:

Specific elastance [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	March 2005
Study Completion Date:	May 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ALI/ARDS patients and healthy subjects	Behavioral: mechanical ventilation measurement of specific lung elastance during mechanical ventilation

Detailed Description:

In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation.

Eligibility

Ages Eligible for Study:	16 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Stable ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

Hemodynamic failure, pneumothorax

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143468

Locations

Italy
Ospedale policlinico
Milano, Italy, 20122

Sponsors and Collaborators

Policlinico Hospital

Investigators

Principal Investigator:

davide chiumello, MD

Policlinico Hospital

More Information

No publications provided by Policlinico Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. Epub 2008 May 1.

Responsible Party:	Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT00143468 History of Changes
Other Study ID Numbers:	1160
Study First Received:	August 31, 2005
Last Updated:	November 30, 2011
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Policlinico Hospital:

gas exchange
respiratory mechanics

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases

Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012