NCT00143468

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration 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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

August 31, 2005

Last Update Submit

November 30, 2011

Conditions

Acute Lung InjuryARDS

Keywords

gas exchangerespiratory mechanics

Outcome Measures

Primary Outcomes (1)

  • Specific elastance

    5 minutes

Study Arms (1)

1

EXPERIMENTAL

ALI/ARDS patients and healthy subjects

Behavioral: mechanical ventilation

Interventions

mechanical ventilationBEHAVIORAL

measurement of specific lung elastance during mechanical ventilation

1

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable ALI/ARDS patients during invasive mechanical ventilation

You may not qualify if:

  • Hemodynamic failure, pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale policlinico

Milan, Milano, 20122, Italy

Location

Related Publications (1)

  • 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.

    PMID: 18451319DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

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

August 31, 2005

First Posted

September 2, 2005

Study Start

March 1, 2005

Primary Completion

March 1, 2007

Study Completion

May 1, 2008

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations

IT(1)