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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014