The Specific Elastance in Acute Lung Injury/Acute Respira... | NCT00143468

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

NCT00143468

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Dec 1, 2011Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Acute Lung Injury
ARDS

Interventions

mechanical ventilation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Mar 2007Actual

Completion Date

May 2008Actual

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2011

Last Update Posted Date

Dec 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ALI/ARDS patients and healthy subjects	Behavioral: mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mechanical ventilation	Behavioral	measurement of specific lung elastance during mechanical ventilation	1

Measure	Description	Time Frame
Specific elastance		5 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

Hemodynamic failure, pneumothorax

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
davide chiumello, MD	Policlinico Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale policlinico		Milan	Milano	20122	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18451319	Derived	Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1.

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D058109	Airway Management
D013812	Therapeutics
D012151	Resuscitation
D004638	Emergency Treatment