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

March 18, 2015 updated by: Davide Chiumello, Policlinico Hospital

Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Patients With Acute Respiratory Distress Syndrome

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARDS
Sedated and mechanically ventilated patients admitted to ICU
Radiation: Chest computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computer Tomography (CT) scan lung recruitment and CT lung weight
Time Frame: Study day (day 1)
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
Study day (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Hospital

Investigators

  • Principal Investigator: Chiumello Davide, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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