Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation (AFON)

June 24, 2009 updated by: Centre Hospitalier Victor Dupouy

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Centre Hospitalier Victor Dupouy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gas exchange
Time Frame: daily during mechanical ventilation
daily during mechanical ventilation
sedation length
Time Frame: ICU discharge
ICU discharge
ventilator alarm rates
Time Frame: daily during mechanical ventilation
daily during mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Time Frame
length of mechanical ventilation
Time Frame: ICU discharge
ICU discharge
ventilator asssociated pneumonia rate
Time Frame: ICU discharge
ICU discharge
SOFA score
Time Frame: daily during mechanical ventilation
daily during mechanical ventilation
death rate
Time Frame: ICU discharge
ICU discharge
cumulative sedation drugs dosage
Time Frame: ICU discharge
ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Victor Dupouy

Investigators

  • Study Director: Hervé MENTEC, MD, Centre Hospitalier Victor Dupouy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2009

Last Update Submitted That Met QC Criteria

June 24, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AFON study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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