Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation

Ventilation, Mechanical Clinical Trial

— AFON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927745
• Other study ID #: AFON study
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2009
• Last updated: June 24, 2009
• Start date: December 2002
• Est. completion date: December 2003

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Victor Dupouy
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ventilation, Mechanical

Intervention

Device:
• AutoFlow mode on Evita 4 Dräger ventilators
Activation of AutoFlow mode during assist-controlled ventilation
• Evita 4 Dräger ventilators
Assist-controlled ventilation without activation of AutoFlow mode

Locations

Country	Name	City	State
France	Centre Hospitalier Victor Dupouy	Argenteuil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Victor Dupouy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gas exchange		daily during mechanical ventilation	Yes
Primary	sedation length		ICU discharge	Yes
Primary	ventilator alarm rates		daily during mechanical ventilation	No
Secondary	length of mechanical ventilation		ICU discharge	Yes
Secondary	ventilator asssociated pneumonia rate		ICU discharge	Yes
Secondary	SOFA score		daily during mechanical ventilation	No
Secondary	death rate		ICU discharge	Yes
Secondary	cumulative sedation drugs dosage		ICU discharge	Yes