NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury

Not Applicable

Completed

• Conditions: Acute Lung Injury; Mechanical Ventilation
• Interventions: Device: PSV - pressure suppot ventilation; Device: NAVA - Neurally Adjusted Ventilatory Assist; Device: NAVA - EMG

• Registration Number: NCT00963066
• Lead Sponsor: University Hospital, Caen

Brief Summary

Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.

Detailed Description

Physiological evaluation of two modes of mechanical ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation, at different levels of ventilator assistance.

Evaluation in term of physiological parameters: Tidal volume, Respiratory rate, Inspiratory effort, PaCO2, evaluation of subject-ventilator synchrony.

Evaluation of physiological response to varying levels of ventilator assistance.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age > 18 years
• Hospitalized in intensive care unit
• Acute Lung Injury
• Intubated or tracheotomized and mechanically ventilated

Exclusion Criteria

• Hemodynamic instability
• Absence of consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure Support ventilation	PSV - pressure suppot ventilation	-
NAVA flow triggering	NAVA - Neurally Adjusted Ventilatory Assist	Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering
NAVA EMG triggering	NAVA - EMG	Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram

Primary Outcome Measures

Name	Time	Method
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)	24 hours

Secondary Outcome Measures

Name	Time	Method
Subject-ventilator synchrony	24 hours

Trial Locations

Locations (1)

CHU de CAEN; 🇫🇷 Caen, France