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

NCT01614873 | Completed DMC

• 1 other identifier: 2012-A0030043
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory System Abnormalities

Keywords

Breathing Pattern; Mechanical Ventilation; Pressure support ventilation; Neurally Adjusted Ventilatory Assist

Outcome Measures

Primary Outcomes (1)

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

  2h

Secondary Outcomes (2)

• Tidal volume evaluated by optoelectronic plethysmography

  2h

• Electrical diaphragmatic activity recorded by mechanical ventilator

  2h

Study Arms (2)

Pressure Support Ventilator

ACTIVE COMPARATOR

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

NAVA

EXPERIMENTAL

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

Interventions

Servo-i® ventilator, MAQUET,Critical Care, Sweden DEVICE

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.

Also known as: PSV

NAVA; Pressure Support Ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Absence of consent
• Pregnant

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• Adep Assistance: collaborator

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

Location

Related Publications (1)

• 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.

  PMID: 24508509 DERIVED

MeSH Terms

Conditions

Respiratory System Abnormalities

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Frédéric Lofaso, MD-PhD

  Hopital Raymond Poincare - Garches - France

  PRINCIPAL INVESTIGATOR

• Nicolas Terzi, MD-PhD

  CHU de Caen - INSERM U1075 - France

  PRINCIPAL INVESTIGATOR

• Pascale Calabrese, PhD

  Laboratoire TIMC-IMAG - La Tronche - France

  STUDY DIRECTOR

• Henri Meric

  EA 4497 - Hopital Raymond Poincare - Garches -France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

FR (1)