A Validation Study of a New System for Measuring the End... | NCT00405002

Studies
A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation

NCT00405002

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Dec 1, 2011Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Respiratory Failure

Interventions

Helium dilution technique, lung 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

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

Nov 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Nov 27, 2006

First Submission Date that Met QC Criteria

Nov 27, 2006

First Posted Date

Nov 29, 2006Estimated

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

In this study the investigators aim to evaluate a new system dedicated to estimate the end expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the helium dilution technique and the computed tomography (CT) scan.

Detailed Description

In this study we aimed to evaluate a new system dedicated to estimate the end expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the Helium dilution technique and the CT scan. We will compare the data considering the CT scan data as the gold standard.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		ALI/ARDS patients	Procedure: Helium dilution technique, lung CT scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Helium dilution technique, lung CT scan	Procedure	Helium dilution technique and lung CT scan	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult intubated subjects

Exclusion Criteria:

Barotrauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder 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			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19046447	Derived	Chiumello D, Cressoni M, Chierichetti M, Tallarini F, Botticelli M, Berto V, Mietto C, Gattinoni L. Nitrogen washout/washin, helium dilution and computed tomography in the assessment of end expiratory lung volume. Crit Care. 2008;12(6):R150. doi: 10.1186/cc7139. Epub 2008 Dec 1.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases