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

NCT ID: NCT01074866

Last Updated: 2012-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non Invasive Ventilation Patient Ventilator Interaction

Keywords

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Mechanical ventilation Non invasive Ventilation Patient-ventilator interaction Pressure support Neurally adjusted ventilatory assist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pressure support

Non invasive ventilation under pressure support (PS)

Group Type NO_INTERVENTION

No interventions assigned to this group

Neurally Adjusted Ventilatory Assist

Non invasive ventilation under Neurally Adjusted ventilatory Assist

Group Type ACTIVE_COMPARATOR

Neurally Adjusted Ventilatory Assist

Intervention Type DEVICE

Non invasive ventilation under Neurally adjusted Ventilatory Assist

Interventions

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Neurally Adjusted Ventilatory Assist

Non invasive ventilation under Neurally adjusted Ventilatory Assist

Intervention Type DEVICE

Other Intervention Names

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NAVA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital St Luc, Brussels

OTHER

Sponsor Role collaborator

University Hospital Sart Tilman, Liege

UNKNOWN

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Notre Dame de Grace Hospital, Gosselies

UNKNOWN

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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HUG, University hospital of Geneva

Principal Investigators

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Didier Tassaux, MD

Role: STUDY_DIRECTOR

HUG, University hospital Geneva

Locations

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St Luc University hospital

Brussels, , Belgium

Site Status

Bernard Lambermont

Liège, , Belgium

Site Status

HUG, University Hospital

Geneva, , Switzerland

Site Status

CHUV University hospital of Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Belgium Switzerland

Other Identifiers

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NAVA_NIV

Identifier Type: -

Identifier Source: org_study_id