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Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation (AFON)

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ClinicalTrials.gov Identifier: NCT00927745
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Ventilation, Mechanical Device: AutoFlow mode on Evita 4 Dräger ventilators Device: Evita 4 Dräger ventilators Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients
Study Start Date : December 2002
Primary Completion Date : December 2003
Study Completion Date : December 2003
Arms and Interventions

Arm Intervention/treatment
Experimental: With AutoFlow
Assist-controlled ventilation with activation of AutoFlow mode
Device: AutoFlow mode on Evita 4 Dräger ventilators
Activation of AutoFlow mode during assist-controlled ventilation
Active Comparator: Without AutoFlow
Assist-controlled ventilation without activation of AutoFlow mode
Device: Evita 4 Dräger ventilators
Assist-controlled ventilation without activation of AutoFlow mode


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927745


Locations
France
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95100
Sponsors and Collaborators
Centre Hospitalier Victor Dupouy
Investigators
Study Director: Hervé MENTEC, MD Centre Hospitalier Victor Dupouy
More Information

Responsible Party: Maurice TOULLALAN, Director, Centre Hospitalier Victor Dupouy
ClinicalTrials.gov Identifier: NCT00927745     History of Changes
Other Study ID Numbers: AFON study
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Keywords provided by Centre Hospitalier Victor Dupouy:
Respiration Artificial
Positive-Pressure Respiration
Critical Care
Intensive Care Units