Respiratory Mechanics and Pleural Effusion | NCT00258518

Studies
Respiratory Mechanics and Pleural Effusion

NCT00258518

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Mar 8, 2012Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Critically Ill
Acute Lung Injury
ARDS

Interventions

mechanical ventilation/CT Scan

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

Mar 2012

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

Nov 2005

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 23, 2005

First Submission Date that Met QC Criteria

Nov 23, 2005

First Posted Date

Nov 24, 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

Mar 7, 2012

Last Update Posted Date

Mar 8, 2012Estimated

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 compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.

Detailed Description

In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		ALI/ARDS patients	Procedure: mechanical ventilation/CT Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mechanical ventilation/CT Scan	Procedure	evaluation of pleural effusion and respiratory mechanics, CT scan	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Role of pleural effusion and respiratory mechanics		1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ALI/ARDS patients underwent invasive mechanical ventilation

Exclusion Criteria:

Haemodynamic instability
Chronic obstructive pulmonary disease (COPD) patients

Accepts Healthy Volunteers

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

ALI/ARDS patients

Sampling Method

Non-Probability Sample

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
Policlinico Hospital		Milan		20122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D055370	Lung Injury

Browse Leaves

Not provided

Browse Branches

Not provided