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PEEP Test and Gas Exchange in ALI/ARDS Patients

Primary Purpose

Acute Respiratory Distress Syndrome

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

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring gas exchange, dead space, respiratory failure, ALI/ARDS patients

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ALI/ARDS patients requiring mechanical ventilation Exclusion Criteria: Hemodynamic instability Barotrauma

Sites / Locations

  • Policlinico Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

ALI/ARDS patients

Outcomes

Primary Outcome Measures

Gas exchange, dead space, respiratory mechanics

Secondary Outcome Measures

Full Information

First Posted
January 30, 2006
Last Updated
September 24, 2008
Sponsor
Policlinico Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00284102
Brief Title
PEEP Test and Gas Exchange in ALI/ARDS Patients
Official Title
Positive End Expiratory Pressure (PEEP) Test and Gas Exchange in ALI/ARDS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Policlinico Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.
Detailed Description
In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
gas exchange, dead space, respiratory failure, ALI/ARDS patients

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ALI/ARDS patients
Intervention Type
Procedure
Intervention Name(s)
Mechanical ventilation
Intervention Description
measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)
Primary Outcome Measure Information:
Title
Gas exchange, dead space, respiratory mechanics
Time Frame
5, 15, 30, 60 minutes from PEEP change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ALI/ARDS patients requiring mechanical ventilation Exclusion Criteria: Hemodynamic instability Barotrauma
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

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PEEP Test and Gas Exchange in ALI/ARDS Patients

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