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Completed

NCT Number: NCT00927745

Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation

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

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Key information

Conditions

Ventilation, Mechanical Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AutoFlow mode on Evita 4 Dräger ventilators

Device

Activation of AutoFlow mode during assist-controlled ventilation

Evita 4 Dräger ventilators

Device

Assist-controlled ventilation without activation of AutoFlow mode

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Victor Dupouy

Other

Registry information

Official study title

Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients

Acronym: AFON

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jun 25, 2009
Registry last updated
Jun 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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