NCT00405002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

1.7 years

First QC Date

November 27, 2006

Last Update Submit

November 30, 2011

Conditions

Respiratory Failure

Keywords

Acute respiratory failure

Study Arms (1)

1

ALI/ARDS patients

Procedure: Helium dilution technique, lung CT scan

Interventions

Helium dilution technique, lung CT scanPROCEDURE

Helium dilution technique and lung CT scan

1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALI/ARDS patients

You may qualify if:

  • Adult intubated subjects

You may not qualify if:

  • Barotrauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 19046447DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 29, 2006

Study Start

November 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations

IT(1)