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

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ClinicalTrials.gov Identifier: NCT00963066
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:
University Hospital, Caen

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

Condition or disease Intervention/treatment
Acute Lung Injury Mechanical Ventilation Device: PSV - pressure suppot ventilation Device: NAVA - Neurally Adjusted Ventilatory Assist Device: NAVA - EMG

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : August 2009
Primary Completion Date : November 2009
Study Completion Date : November 2009


Arm Intervention/treatment
Active Comparator: Pressure Support 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
Experimental: NAVA flow triggering
Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering
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
Experimental: NAVA EMG triggering
Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram
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).



Primary Outcome Measures :
  1. Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Subject-ventilator synchrony [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963066


Locations
France
CHU de CAEN
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Nicolas TERZI, MD University Hospital, Caen

Responsible Party: TERZI Nicolas, CHU de CAEN
ClinicalTrials.gov Identifier: NCT00963066     History of Changes
Other Study ID Numbers: 2009-A00583-54
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010

Keywords provided by University Hospital, Caen:
NAVA
Acute Lung Injury
Pressure Support Ventilation
Intubation
Tracheostomy
Mechanical ventilation

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders