CHU de Bordeaux
Bordeaux, 33000, France
NCT Number: NCT01928238
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bordeaux, 33000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: At inclusion (Day 0)
Time frame: 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.
University Hospital, Bordeaux
Other
Acronym: NAVA-VNI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06578377
Acute Lung Injury, Acute Respiratory Distress
Tehran, Iran
View Trial DetailsNCT02766946
Acute Lung Injury, Acute Respiratory Distress
View Trial DetailsNCT03780933
Acute Lung Injury, Acute Respiratory Distress
Cairo, Egypt
View Trial DetailsNCT01710891
Acute Lung Injury, Acute Respiratory Distress
Minneapolis, Minnesota, United States
View Trial Details