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The Specific Elastance in ARDS Patients: a Pediatric Study

This study has been completed.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital Identifier:
First received: January 13, 2014
Last updated: March 18, 2015
Last verified: March 2015
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.

Condition Intervention
Pediatric ARDS
Other: Lung specific elastance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • Specific elastance of the lung [ Time Frame: 10 minutes from the start of the study ]

Estimated Enrollment: 40
Study Start Date: June 2009
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

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

Exclusion Criteria:

  • Hemodynamic instability
  • Lung diseases other than ARDS
  • Parental refuse
  Contacts and Locations
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Please refer to this study by its identifier: NCT02036801

Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Davide Chiumello, MD, Policlinico Hospital Identifier: NCT02036801     History of Changes
Other Study ID Numbers: policlinico-10
Study First Received: January 13, 2014
Last Updated: March 18, 2015

Keywords provided by Policlinico Hospital:
Specific Elastance
Pediatric patients processed this record on April 28, 2017