The Specific Elastance in Acute Lung Injury /Cute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma - Full Text View

The Specific Elastance in Acute Lung Injury /Cute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma

This study has been completed.

Sponsored by:	Policlinico Hospital
Information provided by:	Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT00143468

Purpose

We aimed to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation.

Condition	Intervention
Acute Lung Injury ARDS	Behavioral: mechanical ventilation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety Study

Official Title:	The Specific Elastance in Acute Lung Injury /Cute 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
1: Active Comparator 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

Publications indexed to this study:

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:	Policlinico Hospital ( Davide Chiumello )
Study ID Numbers:	1160
First Received:	August 31, 2005
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00143468
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Policlinico Hospital:

gas exchange

respiratory mechanics

Study placed in the following topic categories:

Barotrauma

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Respiratory Distress Syndrome, Adult

Wounds and Injuries

Disorders of Environmental Origin

Acute respiratory distress syndrome

ClinicalTrials.gov processed this record on August 28, 2008