The Specific Elastance in ARDS Patients: a Pediatric Study

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02036801
• Collaborator: (none)
• Enrollment: 40
• Location: 1

Study Details

Study Description

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	Phase
Pediatric ARDS	Other: Lung specific elastance

Study Design

• Study Type: Observational
• Anticipated 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: Jun 1, 2009
• Actual Primary Completion Date: Dec 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Specific elastance of the lung [10 minutes from the start of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico	Milan		Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Davide Chiumello, MD, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT02036801
• Other Study ID Numbers: policlinico-10
• First Posted: Jan 15, 2014
• Last Update Posted: Mar 19, 2015
• Last Verified: Mar 1, 2015

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

Study Results

No Results Posted as of Mar 19, 2015