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NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury

Primary Purpose

Acute Lung Injury, Mechanical Ventilation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PSV - pressure suppot ventilation
NAVA - Neurally Adjusted Ventilatory Assist
NAVA - EMG
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Lung Injury focused on measuring NAVA, Acute Lung Injury, Pressure Support Ventilation, Intubation, Tracheostomy, Mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Hospitalized in intensive care unit
  • Acute Lung Injury
  • Intubated or tracheotomized and mechanically ventilated

Exclusion Criteria:

  • Hemodynamic instability
  • Absence of consent

Sites / Locations

  • CHU de CAEN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Pressure Support ventilation

NAVA flow triggering

NAVA EMG triggering

Arm Description

Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering

Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram

Outcomes

Primary Outcome Measures

Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)

Secondary Outcome Measures

Subject-ventilator synchrony

Full Information

First Posted
August 12, 2009
Last Updated
March 2, 2010
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT00963066
Brief Title
NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury
Official Title
NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.
Detailed Description
Physiological evaluation of two modes of mechanical ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation, at different levels of ventilator assistance. Evaluation in term of physiological parameters: Tidal volume, Respiratory rate, Inspiratory effort, PaCO2, evaluation of subject-ventilator synchrony. Evaluation of physiological response to varying levels of ventilator assistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Mechanical Ventilation
Keywords
NAVA, Acute Lung Injury, Pressure Support Ventilation, Intubation, Tracheostomy, Mechanical ventilation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure Support ventilation
Arm Type
Active Comparator
Arm Title
NAVA flow triggering
Arm Type
Experimental
Arm Description
Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering
Arm Title
NAVA EMG triggering
Arm Type
Experimental
Arm Description
Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram
Intervention Type
Device
Intervention Name(s)
PSV - pressure suppot ventilation
Other Intervention Name(s)
PSV
Intervention Description
Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Different levels of pressure support ventilator assistance are tested.
Intervention Type
Device
Intervention Name(s)
NAVA - Neurally Adjusted Ventilatory Assist
Other Intervention Name(s)
NAVA - Flow
Intervention Description
Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Positive pressure, delivered by the machine, is driven using inspiratory flow trigger.
Intervention Type
Device
Intervention Name(s)
NAVA - EMG
Intervention Description
Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. The machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (Eadi). Eadi was obtained trhough a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden).
Primary Outcome Measure Information:
Title
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Subject-ventilator synchrony
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Hospitalized in intensive care unit Acute Lung Injury Intubated or tracheotomized and mechanically ventilated Exclusion Criteria: Hemodynamic instability Absence of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de CAEN
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury

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