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

Primary Purpose

Respiratory System Abnormalities

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Servo-i® ventilator, MAQUET,Critical Care, Sweden
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory System Abnormalities focused on measuring Breathing Pattern, Mechanical Ventilation, Pressure support ventilation, Neurally Adjusted Ventilatory Assist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of consent
  • Pregnant

Sites / Locations

  • Hopital Raymond Poincare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pressure Support Ventilator

NAVA

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)

Secondary Outcome Measures

Tidal volume evaluated by optoelectronic plethysmography
Electrical diaphragmatic activity recorded by mechanical ventilator

Full Information

First Posted
June 6, 2012
Last Updated
April 11, 2013
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Adep Assistance
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1. Study Identification

Unique Protocol Identification Number
NCT01614873
Brief Title
Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation
Official Title
Comparison of Breathing Pattern During PSV and NAVA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Adep Assistance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory System Abnormalities
Keywords
Breathing Pattern, Mechanical Ventilation, Pressure support ventilation, Neurally Adjusted Ventilatory Assist

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure Support Ventilator
Arm Type
Active Comparator
Arm Description
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)
Arm Title
NAVA
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Servo-i® ventilator, MAQUET,Critical Care, Sweden
Other Intervention Name(s)
PSV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time Frame
2h
Secondary Outcome Measure Information:
Title
Tidal volume evaluated by optoelectronic plethysmography
Time Frame
2h
Title
Electrical diaphragmatic activity recorded by mechanical ventilator
Time Frame
2h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years Healthy Subject without any chronic disease Exclusion Criteria: Absence of consent Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Lofaso, MD-PhD
Organizational Affiliation
Hopital Raymond Poincare - Garches - France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Terzi, MD-PhD
Organizational Affiliation
CHU de Caen - INSERM U1075 - France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascale Calabrese, PhD
Organizational Affiliation
Laboratoire TIMC-IMAG - La Tronche - France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Henri Meric
Organizational Affiliation
EA 4497 - Hopital Raymond Poincare - Garches -France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24508509
Citation
Meric H, Calabrese P, Pradon D, Lejaille M, Lofaso F, Terzi N. Physiological comparison of breathing patterns with neurally adjusted ventilatory assist (NAVA) and pressure-support ventilation to improve NAVA settings. Respir Physiol Neurobiol. 2014 May 1;195:11-8. doi: 10.1016/j.resp.2014.01.021. Epub 2014 Feb 5.
Results Reference
derived

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

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