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CompletedNCT00927745AFONUpdated Jun 25, 2009

Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation

A Phase 4 interventional study of AutoFlow mode on Evita 4 Dräger ventilators and Evita 4 Dräger ventilators in Ventilation, Mechanical, sponsored by Centre Hospitalier Victor Dupouy. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-25.

Sponsored by Centre Hospitalier Victor Dupouy · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, "dual-controlled" modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.

02

Conditions studied

  • Ventilation, Mechanical

Keywords

  • Respiration Artificial
  • Positive-Pressure Respiration
  • Critical Care
  • Intensive Care Units
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • coma
  • ventilation longer than 12 hours prior to inclusion
  • pregnancy
  • inclusion in another study
04

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    With AutoFlow

    Assist-controlled ventilation with activation of AutoFlow mode

    Device: AutoFlow mode on Evita 4 Dräger ventilators

  • Active comparator
    Without AutoFlow

    Assist-controlled ventilation without activation of AutoFlow mode

    Device: Evita 4 Dräger ventilators

Interventions

  • DeviceAutoFlow mode on Evita 4 Dräger ventilators

    Activation of AutoFlow mode during assist-controlled ventilation

  • DeviceEvita 4 Dräger ventilators

    Assist-controlled ventilation without activation of AutoFlow mode

05

What researchers measure

Primary outcomes

  1. gas exchange

    Time frame: daily during mechanical ventilation

  2. sedation length

    Time frame: ICU discharge

  3. ventilator alarm rates

    Time frame: daily during mechanical ventilation

Secondary outcomes

  1. length of mechanical ventilation

    Time frame: ICU discharge

  2. ventilator asssociated pneumonia rate

    Time frame: ICU discharge

  3. SOFA score

    Time frame: daily during mechanical ventilation

  4. death rate

    Time frame: ICU discharge

  5. cumulative sedation drugs dosage

    Time frame: ICU discharge

06

Study locations

1 site
  • Centre Hospitalier Victor Dupouy
    Argenteuil, 95100, France
07

Registry details

Key details

Study ID
NCT00927745
Lead sponsor
Centre Hospitalier Victor Dupouy
First posted
Jun 25, 2009
Start date
Dec 2002
Primary completion
Dec 2003
Completion
Dec 2003
Last update
Jun 25, 2009

Study contacts

Hervé MENTEC, MD
study director · Centre Hospitalier Victor Dupouy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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