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Trial record 4 of 4 for:    Open Studies | "Barotrauma"

The Specific Elastance in ARDS Patients: a Pediatric Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Policlinico Hospital
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital Identifier:
First received: January 13, 2014
Last updated: January 14, 2014
Last verified: January 2014

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02036801

Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Davide Chiumello, MD    +39 0255033237   
Principal Investigator: Davide Chiumello, MD         
Sponsors and Collaborators
Policlinico Hospital
  More Information

No publications provided

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: January 14, 2014
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Policlinico Hospital:
Specific Elastance
Pediatric patients processed this record on March 03, 2015