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

Primary Purpose

Acute Lung Injury, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
specific elastance
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Gas exchange, Respiratory mechanics, Ventilator Induced Lung Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

  • Haemodynamic failure, pneumothorax

Sites / Locations

  • Policlinico Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Specific elastance

Secondary Outcome Measures

Full Information

First Posted
December 5, 2007
Last Updated
April 27, 2015
Sponsor
Policlinico Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00568659
Brief Title
The Specific Lung Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients in Supine and Prone Position
Official Title
The Specific Lung Elastance in ALI/ARDS Patients in Supine and Prone Position
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
January 2015 (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 is to study the specific lung elastance in ALI/ARDS patients during invasive mechanical ventilation, in supine and prone position.
Detailed Description
In sedated and paralyzed ALI/ARDS patients, we study and compare the specific lung elastance in supine and prone position 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, Acute Respiratory Distress Syndrome
Keywords
Gas exchange, Respiratory mechanics, Ventilator Induced Lung Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
specific elastance
Intervention Description
The investigators study the specific lung elastance in ALI/ARDS patients in supine and prone position.
Primary Outcome Measure Information:
Title
Specific elastance
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ALI/ARDS patients during invasive mechanical ventilation Exclusion Criteria: Haemodynamic 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
Policlinico Hospital
City
Milano
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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