NCT00927745

Brief Summary

The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_4

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, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

Enrollment Period

1 year

First QC Date

June 24, 2009

Last Update Submit

June 24, 2009

Conditions

Ventilation, Mechanical

Keywords

Respiration ArtificialPositive-Pressure RespirationCritical CareIntensive Care Units

Outcome Measures

Primary Outcomes (3)

  • gas exchange

    daily during mechanical ventilation

  • sedation length

    ICU discharge

  • ventilator alarm rates

    daily during mechanical ventilation

Secondary Outcomes (5)

  • length of mechanical ventilation

    ICU discharge

  • ventilator asssociated pneumonia rate

    ICU discharge

  • SOFA score

    daily during mechanical ventilation

  • death rate

    ICU discharge

  • cumulative sedation drugs dosage

    ICU discharge

Study Arms (2)

With AutoFlow

EXPERIMENTAL

Assist-controlled ventilation with activation of AutoFlow mode

Device: AutoFlow mode on Evita 4 Dräger ventilators

Without AutoFlow

ACTIVE COMPARATOR

Assist-controlled ventilation without activation of AutoFlow mode

Device: Evita 4 Dräger ventilators

Interventions

AutoFlow mode on Evita 4 Dräger ventilatorsDEVICE

Activation of AutoFlow mode during assist-controlled ventilation

With AutoFlow
Evita 4 Dräger ventilatorsDEVICE

Assist-controlled ventilation without activation of AutoFlow mode

Without AutoFlow

Eligibility Criteria

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

You may qualify if:

  • adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days

You may not qualify if:

  • coma
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hervé MENTEC, MD

    Centre Hospitalier Victor Dupouy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

December 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

June 25, 2009

Record last verified: 2009-06

Locations

FR(1)