The Specific Elastance in ARDS Patients: a Pediatric Study

Pediatric ARDS Clinical Trial

Official title:

The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036801
• Other study ID #: policlinico-10
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: March 18, 2015
• Start date: June 2009

Study information

• Verified date: March 2015
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Hemodynamic instability

• Lung diseases other than ARDS

• Parental refuse

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pediatric ARDS

Intervention

Other:
• Lung specific elastance
Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes

Locations

Country	Name	City	State
Italy	Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific elastance of the lung		10 minutes from the start of the study	Yes