Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation (AFON)

Centre Hospitalier Victor Dupouy

Status and phase: Completed; Phase 4

Conditions: Ventilation, Mechanical

Treatments: Device: Evita 4 Dräger ventilators; Device: AutoFlow mode on Evita 4 Dräger ventilators

Study type: Interventional

Funder types: Other

Identifiers

NCT00927745

AFON study

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

With AutoFlow

Experimental group

Description:

Assist-controlled ventilation with activation of AutoFlow mode

Treatment:

Device: AutoFlow mode on Evita 4 Dräger ventilators

Without AutoFlow

Active Comparator group

Description:

Assist-controlled ventilation without activation of AutoFlow mode

Treatment:

Device: Evita 4 Dräger ventilators