Back to resultsThe Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients
Primary Purpose
Acute Lung Injury, ARDS
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury focused on measuring gas exchange, respiratory mechanics
Eligibility Criteria
Inclusion Criteria: Stable ALI/ARDS patients during invasive mechanical ventilation Exclusion Criteria: Hemodynamic failure, pneumothorax
Sites / Locations
- Ospedale policlinico
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
ALI/ARDS patients and healthy subjects
Outcomes
Primary Outcome Measures
Specific elastance
Secondary Outcome Measures
Full Information
NCT ID
NCT00143468
First Posted
August 31, 2005
Last Updated
November 30, 2011
Sponsor
Policlinico Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00143468
Brief Title
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients
Official Title
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to study the specific elastance in ALI/ARDS patients during invasive 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, ARDS
Keywords
gas exchange, respiratory mechanics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ALI/ARDS patients and healthy subjects
Intervention Type
Behavioral
Intervention Name(s)
mechanical ventilation
Intervention Description
measurement of specific lung elastance during mechanical ventilation
Primary Outcome Measure Information:
Title
Specific elastance
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stable ALI/ARDS patients during invasive mechanical ventilation
Exclusion Criteria:
Hemodynamic failure, pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
davide chiumello, MD
Organizational Affiliation
Policlinico Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18451319
Citation
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. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1.
Results Reference
derived
Learn more about this trial
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients
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