The Specific Elastance in ARDS Patients: a Pediatric Study

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

The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study

Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

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
      • Milan, Italy, 20122
        • Fondazione IRCC 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

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ARDS pediatric patients in mechanical ventilation or patients with healthy lung treated with mechanical ventilation for clinical purposes

Description

Inclusion Criteria:

  • ARDS (Berlin Definition Criteria) or mechanical ventilation in healthy lungs

Exclusion Criteria:

  • Hemodynamic instability
  • Lung diseases other than ARDS
  • Parental refuse

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
Patients with ARDS (according to the Berlin Definition criteria) in mechanical ventilation
Other: Lung specific elastance
Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes
Healthy control
Patients with healthy lung supported with mechanical ventilation for clinical purposes
Other: Lung specific elastance
Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specific elastance of the lung
Time Frame: 10 minutes from the start of the study
10 minutes from the start of the study

Collaborators and Investigators

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

Sponsor

Policlinico Hospital

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

June 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 15, 2014

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

Keywords

Other Study ID Numbers

  • policlinico-10

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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