NCT00568659

Brief Summary

The investigators aim is to study the specific lung elastance in ALI/ARDS patients during invasive mechanical ventilation, in supine and prone position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

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

December 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

December 5, 2007

Last Update Submit

April 27, 2015

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

Gas exchangeRespiratory mechanicsVentilator Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

  • Specific elastance

    5 minutes

Study Arms (1)

1

EXPERIMENTAL
Procedure: specific elastance

Interventions

specific elastancePROCEDURE

The investigators study the specific lung elastance in ALI/ARDS patients in supine and prone position.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ALI/ARDS patients during invasive mechanical ventilation

You may not qualify if:

  • Haemodynamic failure, pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress SyndromeVentilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2010

Study Completion

January 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(1)