Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation (AFON)

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Victor Dupouy
ClinicalTrials.gov Identifier:
NCT00927745
First received: June 24, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Ventilation, Mechanical
Device: AutoFlow mode on Evita 4 Dräger ventilators
Device: Evita 4 Dräger ventilators
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients

Further study details as provided by Centre Hospitalier Victor Dupouy:

Primary Outcome Measures:
  • gas exchange [ Time Frame: daily during mechanical ventilation ] [ Designated as safety issue: Yes ]
  • sedation length [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
  • ventilator alarm rates [ Time Frame: daily during mechanical ventilation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of mechanical ventilation [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
  • ventilator asssociated pneumonia rate [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
  • SOFA score [ Time Frame: daily during mechanical ventilation ] [ Designated as safety issue: No ]
  • death rate [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
  • cumulative sedation drugs dosage [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: December 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maurice TOULLALAN, Director, Centre Hospitalier Victor Dupouy
ClinicalTrials.gov Identifier: NCT00927745     History of Changes
Other Study ID Numbers: AFON study
Study First Received: June 24, 2009
Last Updated: June 24, 2009
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on April 15, 2014