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

Not Applicable

Completed

• Conditions: Respiratory System Abnormalities
• Interventions: Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden

• Registration Number: NCT01614873
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-05
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• Absence of consent
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure Support Ventilator	Servo-i® ventilator, MAQUET,Critical Care, Sweden	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)
NAVA	Servo-i® ventilator, MAQUET,Critical Care, Sweden	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)

Primary Outcome Measures

Name	Time	Method
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)	2h

Secondary Outcome Measures

Name	Time	Method
Tidal volume evaluated by optoelectronic plethysmography	2h
Electrical diaphragmatic activity recorded by mechanical ventilator	2h

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France