Clinical Trials Directory

Trials / Completed

CompletedNCT01928238

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENoninvasive neurally adjusted ventilatory assist (NIV-NAVA).
DEVICENoninvasive pressure support ventilation (NPSV)

Timeline

Start date
2012-08-01
Primary completion
2014-12-01
Completion
2015-01-01
First posted
2013-08-23
Last updated
2015-06-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01928238. Inclusion in this directory is not an endorsement.