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Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00267241
First received: December 19, 2005
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome, Adult
 Other: Mechanical Ventilation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients

Resource links provided by NLM:

MedlinePlus related topics: Gas
U.S. FDA Resources

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • Gas exchange and respiratory mechanics [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2005
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ALI/ARDS patients
 Other: Mechanical Ventilation
Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ALI/ARDS

Exclusion Criteria:

  • COPD patients
  • Barotrauma
  • Hemodynamic instability
  • Age less than 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267241

Locations
Italy
Policlinico Hospital
Milano, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
  More Information

No publications provided

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00267241     History of Changes
Other Study ID Numbers: 1600
Study First Received: December 19, 2005
Last Updated: November 30, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Policlinico Hospital:
ARDS
ALI
respiratory mechanics
gas exchange
assisted ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on May 19, 2013