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Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)

This study is currently recruiting participants.
Verified March 2013 by Policlinico Hospital
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01670747
First received: August 14, 2012
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

In this study gas-exchange and respiratory mechanics variations to PEEP change will be correlated to CT lung morphological modifications assessed at different airway pressures (5, 15, 30 and 45 cmH2O).


Condition Intervention
ARDS: Acute Respiratory Distress Syndrome
 Radiation: Chest computed tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Patients With Acute Respiratory Distress Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • Computer Tomography (CT) scan lung recruitment and CT lung weight [ Time Frame: Study day (day 1) ] [ Designated as safety issue: No ]
    Aim of the study is to determine the relationship between the opening pressures (recruitment) and closing pressures (PEEP) in order to prevent the opening and closing of the lung parenchyma


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ARDS
Sedated and mechanically ventilated patients admitted to ICU
 Radiation: Chest computed tomography

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to ICU with diagnosis of ARDS who required mechanical ventilation

Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
  • Mechanical ventilation

Exclusion Criteria:

  • Clinical diagnosis of chronic obstructive pulmonary disease
  • Clinical diagnosis of pneumothorax
  • Haemodynamic instability
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670747

Contacts
Contact: Chiumello Davide, MD +39-02-5503-3237 chiumello@libero.it

Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Contact: Chiumello Davide, MD     +39-02-5503-3237        
Principal Investigator: Chiumello Davide, MD            
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Chiumello Davide, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  More Information

Publications:

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01670747     History of Changes
Other Study ID Numbers: 201208
Study First Received: August 14, 2012
Last Updated: March 6, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Pulmonary Atelectasis
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 21, 2013