Back to resultsEffects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
Primary Purpose
Respiratory Distress Syndrome, Adult
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 Respiratory Distress Syndrome, Adult focused on measuring ARDS, ALI, respiratory mechanics, gas exchange, assisted ventilation
Eligibility Criteria
Inclusion Criteria: Patients with ALI/ARDS Exclusion Criteria: COPD patients Barotrauma Hemodynamic instability Age less than 18
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 and respiratory mechanics
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00267241
Brief Title
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
Official Title
Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (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 aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.
Detailed Description
ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
ARDS, ALI, respiratory mechanics, gas exchange, assisted ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ALI/ARDS patients
Intervention Type
Other
Intervention Name(s)
Mechanical Ventilation
Intervention Description
Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)
Primary Outcome Measure Information:
Title
Gas exchange and respiratory mechanics
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with ALI/ARDS
Exclusion Criteria:
COPD patients
Barotrauma
Hemodynamic instability
Age less than 18
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
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
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