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CompletedNCT02036801Updated Mar 19, 2015

The Specific Elastance in ARDS Patients: a Pediatric Study

An observational study in Pediatric ARDS, sponsored by Policlinico Hospital. Completed at 1 site in Italy. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Policlinico Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
1 Year to 12 Years
Sex
All
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Study 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.

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Conditions studied

  • Pediatric ARDS

Keywords

  • ARDS
  • Lung
  • Specific Elastance
  • Pediatric patients
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In context

Lead sponsor

Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • ARDS

    Patients with ARDS (according to the Berlin Definition criteria) in mechanical ventilation

    Other: Lung specific elastance

  • Healthy control

    Patients with healthy lung supported with mechanical ventilation for clinical purposes

    Other: Lung specific elastance

Interventions

  • OtherLung specific elastance

    Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes

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What researchers measure

Primary outcomes

  1. Specific elastance of the lung

    Time frame: 10 minutes from the start of the study

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Study locations

1 site
  • Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico
    Milan, 20122, Italy
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References and documents

Publications

  • Chiumello D, Chidini G, Calderini E, Colombo A, Crimella F, Brioni M. Respiratory mechanics and lung stress/strain in children with acute respiratory distress syndrome. Ann Intensive Care. 2016 Dec;6(1):11. doi: 10.1186/s13613-016-0113-0. Epub 2016 Feb 5. PubMed 26847436 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02036801
Lead sponsor
Policlinico Hospital
Responsible party
Davide Chiumello (MD, Policlinico Hospital) — Principal investigator
First posted
Jan 15, 2014
Start date
Jun 2009
Primary completion
Dec 2014
Last update
Mar 19, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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