Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation - Full Text View

Purpose

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

Condition	Intervention
Respiratory System Abnormalities	Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	Comparison of Breathing Pattern During PSV and NAVA

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MedlinePlus related topics: Critical Care

U.S. FDA Resources

Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:

Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA) [ Time Frame: 2h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	10
Study Start Date:	May 2012
Study Completion Date:	August 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)	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
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)	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

Arms

Assigned Interventions

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)

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

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)

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age > 18 years
Healthy Subject without any chronic disease

Exclusion Criteria:

Absence of consent
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614873

Locations

France
Hopital Raymond Poincare
Garches, France, 92380

Sponsors and Collaborators

Centre d'Investigation Clinique et Technologique 805

Adep Assistance

Investigators

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

More Information

No publications provided

Responsible Party:	Lofaso, MD-PhD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:	NCT01614873 History of Changes
Other Study ID Numbers:	2012-A0030043
Study First Received:	June 6, 2012
Last Updated:	April 11, 2013
Health Authority:	France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre d'Investigation Clinique et Technologique 805:

Breathing Pattern
Mechanical Ventilation
Pressure support ventilation
Neurally Adjusted Ventilatory Assist

Additional relevant MeSH terms:

Congenital Abnormalities
Respiratory Aspiration
Respiratory System Abnormalities
Respiration Disorders

Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013