Neurally Adjusted Ventilatory Assist for Non Invasive Ven... | NCT01074866

Studies
Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction

NCT01074866

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Sep 21, 2012Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Non Invasive Ventilation
Patient Ventilator Interaction

Interventions

Neurally Adjusted Ventilatory Assist

Countries

Belgium
Switzerland

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

Jan 2010

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

Jul 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

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

Sep 20, 2012

Last Update Posted Date

Sep 21, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Name	Class
University Hospital St Luc, Brussels	OTHER
University Hospital Sart Tilman, Liege	UNKNOWN
University of Lausanne Hospitals	OTHER
Notre Dame de Grace Hospital, Gosselies

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

Detailed Description

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pressure support	No Intervention	Non invasive ventilation under pressure support (PS)
Neurally Adjusted Ventilatory Assist	Active Comparator	Non invasive ventilation under Neurally Adjusted ventilatory Assist	Device: Neurally Adjusted Ventilatory Assist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurally Adjusted Ventilatory Assist	Device	Non invasive ventilation under Neurally adjusted Ventilatory Assist	Neurally Adjusted Ventilatory Assist

Measure	Description	Time Frame
Patient-ventilator synchronization parameters

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin

Exclusion Criteria:

severe hypoxemia requiring an FIO2>0.6
hemodynamic instability
known oesophageal problem
active upper gastro-intestinal bleeding
any other contraindication to the insertion of a naso-gastric tube
impaired consciousness or absence of patient cooperation
facial or laryngeal lesions contraindicating the use of NIV
poor short term prognosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Didier Tassaux, MD	HUG, University hospital Geneva	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Luc University hospital		Brussels			Belgium
Bernard Lambermont

Intervention Browse Module

MeSH Terms

ID	Term
D059725	Interactive Ventilatory Support

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided