Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation

This study has been completed.
Sponsor:
Collaborator:
Adep Assistance
Information provided by (Responsible Party):
Lofaso, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01614873
First received: June 6, 2012
Last updated: April 11, 2013
Last verified: April 2013

June 6, 2012
April 11, 2013
May 2012
May 2012   (final data collection date for primary outcome measure)
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA) [ Time Frame: 2h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01614873 on ClinicalTrials.gov Archive Site
  • Tidal volume evaluated by optoelectronic plethysmography [ Time Frame: 2h ] [ Designated as safety issue: No ]
  • Electrical diaphragmatic activity recorded by mechanical ventilator [ Time Frame: 2h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation
Comparison of Breathing Pattern During PSV and NAVA

Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist)

Eligibility : healthy subject without respiratory complications in the past

Subjects will breath spontaneously without mechanical ventilation, with Pressure Support Ventilation and with Neurally Adjusted Ventilatory Assist during.

Three levels of pressurisation will be tested : 5 cmH2O, 8 cmH2O and 12 cmH2O Duration of each condition will be about 15 minutes.

Measurements will include:Flow, airway pressure, SaO2, PtCO2, diaphragmatic electromyography, chest wall motion by optoelectronic plethysmography

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Respiratory System Abnormalities
Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden
Electrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). Subject will be ventilated with a mouthpiece interface. NAVA will be compared to Pressure Support using the same ventilator. Once the pattern of breathing will be stabilized (10 minutes) in each condition (see arm) the following parameters will be recorded during 5 minutes and compared : tidal volume, inspiratory time, expiratory time, transcutaneous CO2 pressure, diaphragmatic Emg activity, delay between the inspiratory activity initiation and positive pressure initiation, delay between the end of the inspiratory effort and the end of pressurisation.
Other Name: PSV
  • Active Comparator: Pressure Support Ventilator

    Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden).

    During pressure support the inspiratory muscles are assisted by a constant inspiratory pressure adjusted by the prescriptor and applied to the airway by either an invasive or a non invasive interface. Then the subject initiate the inspiratory effort and a constant pressure is delivered to the airway in order to assist inspiration. Three levels of pressure will be tested (5 cmH2O, 8 cmH2O and 12 cmH2O)

    Intervention: Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden
  • Experimental: NAVA
    Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram. Electrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). During NAVA the inspiratory muscles are assisted by a pressure which is proportional to this electrical activity. Then the subject initiate the inspiratory effort and a pressure proportional to the integrated EMG activity is delivered to the airway in order to assist inspiration. The adjustment of the level of NAVA (expressed in cmH2O/microvolt) will be adjusted in order to obtain a peak pressure similar to pressure support (5 cmH2O, 8 cmH2O and 12 cmH2O)
    Intervention: Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Healthy Subject without any chronic disease

Exclusion Criteria:

  • Absence of consent
  • Pregnant
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01614873
2012-A0030043
Yes
Lofaso, Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
Adep Assistance
Principal Investigator: Frédéric Lofaso, MD-PhD Hopital Raymond Poincare - Garches - France
Principal Investigator: Nicolas Terzi, MD-PhD CHU de Caen - INSERM U1075 - France
Study Director: Pascale Calabrese, PhD Laboratoire TIMC-IMAG - La Tronche - France
Principal Investigator: Henri Meric EA 4497 - Hopital Raymond Poincare - Garches -France
Centre d'Investigation Clinique et Technologique 805
April 2013

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