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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00963066
First received: August 12, 2009
Last updated: March 2, 2010
Last verified: March 2010

August 12, 2009
March 2, 2010
August 2009
November 2009   (final data collection date for primary outcome measure)
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00963066 on ClinicalTrials.gov Archive Site
Subject-ventilator synchrony [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury
NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.

Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Acute Lung Injury
  • Mechanical Ventilation
  • Device: PSV - pressure suppot ventilation
    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.
    Other Name: PSV
  • Device: NAVA - Neurally Adjusted Ventilatory Assist
    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.
    Other Name: NAVA - Flow
  • Device: NAVA - EMG
    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).
    Other Name: NAVA - EMG
  • Active Comparator: Pressure Support ventilation
    Intervention: Device: PSV - pressure suppot ventilation
  • Experimental: NAVA flow triggering
    Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering
    Intervention: Device: NAVA - Neurally Adjusted Ventilatory Assist
  • Experimental: NAVA EMG triggering
    Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram
    Intervention: Device: NAVA - EMG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00963066
2009-A00583-54
No
TERZI Nicolas, CHU de CAEN
University Hospital, Caen
Not Provided
Principal Investigator: Nicolas TERZI, MD University Hospital, Caen
University Hospital, Caen
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP