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The Specific Elastance in ARDS Patients: a Pediatric Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036801
First Posted: January 15, 2014
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
  Purpose
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 Davide Chiumello, 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
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: January 13, 2014
First Posted: January 15, 2014
Last Update Posted: March 19, 2015
Last Verified: March 2015

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