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The Specific Elastance in ARDS Patients: a Pediatric Study

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ClinicalTrials.gov Identifier: NCT02036801
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital

Brief Summary:
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 or disease Intervention/treatment
Pediatric ARDS Other: Lung specific elastance

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study
Study Start Date : June 2009
Actual Primary Completion Date : December 2014

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



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


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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036801


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT02036801     History of Changes
Other Study ID Numbers: policlinico-10
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Davide Chiumello, Policlinico Hospital:
ARDS
Lung
Specific Elastance
Pediatric patients