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

April 11, 2013 updated by: Lofaso, Centre d'Investigation Clinique et Technologique 805

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hopital Raymond Poincare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of consent
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • PSV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time Frame: 2h
2h

Secondary Outcome Measures

Outcome Measure
Time Frame
Tidal volume evaluated by optoelectronic plethysmography
Time Frame: 2h
2h
Electrical diaphragmatic activity recorded by mechanical ventilator
Time Frame: 2h
2h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 12, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A0030043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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