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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
  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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Centre d'Investigation Clinique et Technologique 805

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Respiratory System Abnormalities
Congenital Abnormalities
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014