NCT00267241

Brief Summary

The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

8.9 years

First QC Date

December 19, 2005

Last Update Submit

April 27, 2015

Conditions

Respiratory Distress Syndrome, Adult

Keywords

ARDSALIrespiratory mechanicsgas exchangeassisted ventilation

Outcome Measures

Primary Outcomes (1)

  • Gas exchange and respiratory mechanics

    5 minutes

Study Arms (1)

1

EXPERIMENTAL

ALI/ARDS patients

Other: Mechanical Ventilation

Interventions

Mechanical VentilationOTHER

Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)

1

Eligibility Criteria

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

You may qualify if:

  • Patients with ALI/ARDS

You may not qualify if:

  • COPD patients
  • Barotrauma
  • Hemodynamic instability
  • Age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 20, 2005

Study Start

December 1, 2005

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(1)