Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.

Not Applicable

Completed

• Conditions: Acute Respiratory Distress
• Interventions: Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).; Device: Noninvasive pressure support ventilation (NPSV)

• Registration Number: NCT01928238
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.

Detailed Description

Reintubation, which occurs after planned extubation, is a relevant consequence of respiratory failure after extubation. The early use of noninvasive pressure support ventilation averted respiratory failure after extubation in patients at increased risk. However patient tolerance to the technique is a critical factor determining its success. One of the key factors determining tolerance to Non Invasive Ventilation (NIV) is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's settings, known as patient ventilator interaction. Optimal patient-ventilator synchrony during NIV can prove very difficult to achieve due to the presence of leaks, the type of interface which can interfere with various aspects of ventilator function. Patient ventilator synchrony during NPSV can be compromised when using conventional pneumatic triggering, with the ventilator-delivered inspiratory support starting after the patient's inspiratory effort. The switch from inspiration to expiration (cycling-off) should, ideally, coincide with the end of the patient's inspiratory effort. However greater asynchrony at the end of inspiration, with the ventilator cycling off either too early or too late compared to the end of the patient's inspiratory effort can be observed during NPSV. A possible solution is to replace the pneumatic triggering with neural triggering and cycling off using the diaphragm electrical activity (Eadi). Neurally adjusted ventilatory assist (NAVA) uses the electrical activity of the diaphragm to control the timing and pressure of the ventilation delivered. The ventilator is triggered, limited and cycled-off directly by Eadi. The Eadi is measured by a multiple array oesophageal electrode. The array of bipolar electrodes can be mounted on a feeding tube, which is routinely introduced in critically ill patients.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).	Patients will have two 20-minute noninvasive periods : Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV)
Arm 2	Noninvasive pressure support ventilation (NPSV)	Patients will have two 20-minute noninvasive periods : Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)
Arm 2	Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).	Patients will have two 20-minute noninvasive periods : Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)
Arm 1	Noninvasive pressure support ventilation (NPSV)	Patients will have two 20-minute noninvasive periods : Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV)

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle effort	At inclusion (day 0)	The primary endpoint variable is the inspiratory muscle effort. To estimate the inspiratory effort, we will determine the transdiaphragmatic pressure (Pdi), the transdiaphragmatic pressure time product per breath (PTPdi/b) or per minute (PTPdi/min) and the Electrical Activity of the Diaphragm (EADI)max.

Secondary Outcome Measures

Name	Time	Method
Patient comfort	At inclusion (Day 0)	Patient comfort will be assessed using a five-item semi quantitative scale: 1, uncomfortable; 2, somewhat uncomfortable; 3, acceptable; 4, somewhat comfortable; and 5, comfortable.
patient ventilator synchrony	At inclusion (Day 0)	Patient ventilator synchrony will be identified by estimating the following variables: autocycled breaths, ineffective inspiratory effort, the inspiratory trigger delay, the expiratory trigger delay and the time of synchrony between muscle effort and ventilator support.
gas exchange	At inclusion (Day 0)

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France