The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00143468
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 38
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The investigators aim to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury; ARDS	Behavioral: mechanical ventilation	N/A

Detailed Description

In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ALI/ARDS patients and healthy subjects	Behavioral: mechanical ventilation; measurement of specific lung elastance during mechanical ventilation

Outcome Measures

Primary Outcome Measures

1. Specific elastance [5 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Stable ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

• Hemodynamic failure, pneumothorax

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale policlinico	Milano		Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

• Principal Investigator: davide chiumello, MD, Policlinico Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Davide Chiumello, MD, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT00143468
• Other Study ID Numbers: 1160
• First Posted: Sep 2, 2005
• Last Update Posted: Dec 1, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Davide Chiumello, MD, Policlinico Hospital: gas exchange; respiratory mechanics
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Wounds and Injuries

Study Results

No Results Posted as of Dec 1, 2011