Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927745

Acronym

AFON

Enrollment

Registered

2009-06-25

Start date

2002-12-31

Completion date

2003-12-31

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation, Mechanical

Keywords

Respiration Artificial, Positive-Pressure Respiration, Critical Care, Intensive Care Units

Brief summary

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

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.

Interventions

DEVICEAutoFlow mode on Evita 4 Dräger ventilators

Activation of AutoFlow mode during assist-controlled ventilation

DEVICEEvita 4 Dräger ventilators

Assist-controlled ventilation without activation of AutoFlow mode

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
gas exchange	daily during mechanical ventilation
sedation length	ICU discharge
ventilator alarm rates	daily during mechanical ventilation

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026