Clinical Evaluation of AutoFlow Mode During Mechanical Ve... | NCT00927745

Studies
Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation

NCT00927745

Sponsor

Centre Hospitalier Victor Dupouy

Status

Completed

Last Update Posted

Jun 25, 2009Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Ventilation, Mechanical

Interventions

AutoFlow mode on Evita 4 Dräger ventilators
Evita 4 Dräger ventilators

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 24, 2009

First Posted Date

Jun 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2009

Last Update Posted Date

Jun 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With AutoFlow	Experimental	Assist-controlled ventilation with activation of AutoFlow mode	Device: AutoFlow mode on Evita 4 Dräger ventilators
Without AutoFlow	Active Comparator	Assist-controlled ventilation without activation of AutoFlow mode	Device: Evita 4 Dräger ventilators

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AutoFlow mode on Evita 4 Dräger ventilators	Device	Activation of AutoFlow mode during assist-controlled ventilation	With AutoFlow

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
length of mechanical ventilation		ICU discharge
ventilator asssociated pneumonia rate		ICU discharge
SOFA score

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hervé MENTEC, MD	Centre Hospitalier Victor Dupouy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Victor Dupouy		Argenteuil		95100	France

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided