NCT00202098

Brief Summary

The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

8 years

First QC Date

September 12, 2005

Last Update Submit

March 18, 2015

Conditions

ARDS

Keywords

ARDSmechanical ventilationvariable ventilationchaotic ventilation

Outcome Measures

Primary Outcomes (1)

  • Gas exchange and respiratory mechanics

    within the first 60 minutes from the ventilatory change

Study Arms (1)

1

EXPERIMENTAL

ALI/ARDS patients

Procedure: Variable ventilation

Interventions

Variable ventilationPROCEDURE

Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period the investigators will record the gas exchange parameters and the mechanics of the respiratory system.

1

Eligibility Criteria

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

You may qualify if:

  • Patients with ARDS criteria

You may not qualify if:

  • Age less than 18 years
  • Severe haemodynamic instability
  • Patients with clinical or instrumental evidence of flow-limitation (i.e., PEEPi)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, Italy

Location

Study Officials

  • Paolo Taccone, MD

    Policlinico Hospital Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Primary Completion

March 1, 2013

Study Completion

March 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

IT(1)