Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04068558 |
Other study ID # |
EASYNNEO |
Secondary ID |
2019-A00420-57 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 9, 2019 |
Est. completion date |
March 11, 2021 |
Study information
Verified date |
June 2021 |
Source |
Centre Hospitalier Intercommunal Creteil |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA
using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby
capsule) synchronized nasal intermittent positive pressure ventilation (sNIPPV) using the
Infant Flow CPAP device (Care Fusion, USA).
All of the data obtained can be used to develop a large-scale study aimed at reducing the
rate of re-intubation in the study population (pilot study). In fact, the re-intubation
criteria for extremely premature children are based on clinical criteria (desaturations,
apnea, signs of respiratory control) and paraclinical criteria (FiO2, Potential hydrogen
(pH), PCO2).
The results of this pilot study will help to develop an adapted methodology and to calculate
a sample size to compare the 2 modes of NIV to the test on a clinical criterion: the rate of
re-intubation after extubation, which is classically high in these patients.
Description:
The use of non-invasive ventilation has significantly reduced morbidity and mortality in
premature newborns by reducing the pulmonary lesions caused by invasive ventilation.
Currently, variable flow continuous positive airway pressure (CPAP) devices, such as the
infant flow® driver, are considered more efficient than constant flow pressure sources. Nasal
intermittent positive pressure ventilation, as compared to CPAP, might reduce the extubation
failure rate, but has no impact on mortality or bronchopulmonary dysplasia. However, data is
lacking on the interest of synchronization and on the effect of the different available
interfaces (prongs, masks, cannulas). In addition, the ventilatory characteristics (high
respiratory rate and low inspiratory effort) of the premature infant increase the risk of
asynchrony between the patient and the ventilator, which is a major cause of poor tolerance
for this type of ventilation.
NAVA (neurally adjusted ventilatory assist) is a recent ventilatory mode that offers
proportional assistance to respiratory work based on the measured electrical activity of the
diaphragm via oesophageal electrodes. It thus allows a regulation of inspiratory pressures
and time by the patient him/herself. The physiological effects of NAVA have been primarily
described in intubated neonates and studies have shown a significantly improved
synchronization and significantly decreased inspiratory pressures in patients ventilated with
NAVA compared to intermittent controlled ventilatory support. However, the currently
available evidence is limited and no beneficial effect on morbidity or mortality has been
identified so far .
There are few studies on noninvasive NAVA (NIV-NAVA) conducted exclusively in neonates, most
of which included a limited number of patients. Only one study to date compared NIV-NAVA to
another synchronized NIV mode (NIV pressure support) using the Servo-i ventilator. This
prospective crossover study found a significant decrease in peak inspiratory pressure (PIP),
FiO2, frequency and length of desaturations in the NIV-NAVA group.
Decreased asynchrony has been observed during NIV-NAVA as compared to pressure-support NIV In
adult patients and in 6 children hospitalized in the Pediatric ICU (median age 18 months).
In premature neonates, variable flow CPAP is preferentially used. Synchronized intermittent
positive pressure can be delivered using a variable flow device and a Graseby abdominal
capsule. Since variable flow CPAP is considered the most efficient pressure generator, it is
legitimate to compare synchronization performance of the variable flow synchronized nasal
intermittent positive pressure ventilation (sNIPPV) to NIV-NAVA. This comparison has never
been performed so far, to our knowledge.
We hypothesize that synchronization will be markedly improved with NIV-NAVA as compared to
sNIPPV.