Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
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|ClinicalTrials.gov Identifier: NCT03242057|
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : June 25, 2018
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are the most commonly used.
A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared to nCPAP (30% vs. 40%)
NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported to improve patient - ventilator synchrony and minimize mean airway pressure and ability to wean an infant from a ventilator. However till date there has been no head to head comparison of extubation failure in infants managed on NAVA with conventional ventilator strategies.
In this study the investigators aim to compare primary extubation failure rates in infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA ventilator settings and will be assessed for primary extubation failure (defined as reintubation within 5 days after an elective extubation).
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infant BPD - Bronchopulmonary Dysplasia Barotrauma||Other: NAVA Other: NIPPV||Not Applicable|
Mechanical ventilation is needed for most preterm infants to maintain adequate oxygenation and ventilation. However the coexistence of lung immaturity, weak respiratory drive, excessively compliant chest wall, and surfactant deficiency often contribute to dependency on mechanical ventilation during the first days or weeks after birth.
Prolonged mechanical ventilation is associated with high mortality and morbidities including ventilator-associated pneumonia, pneumothorax, and bronchopulmonary dysplasia (BPD). Each additional week of mechanical ventilation is reported to be associated with an increase in the risk of neurodevelopmental impairment. Reduction in the need and duration of invasive mechanical ventilation may potentially improve outcome of preterm infants.
Extubation failure has been independently associated with increased mortality, longer hospitalization, and more days on oxygen and ventilatory support. It is critical, therefore, to attempt extubation early and at a time when successful extubation is likely.
A recent Cochrane review compared the use of nasal intermittent positive pressure ventilation (NIPPV) with nasal continuous positive airway pressure (nCPAP) in preterm infants after extubation and found that NIPPV may be more effective than nCPAP at decreasing extubation failure.
The feasibility of NAVA use has been described in neonatal and pediatric patients. Several studies cite a decrease in peak inspiratory pressures, improved synchrony in triggering, and more appropriate termination of positive pressure support. Some studies have reported lower work of breathing, PaO2/FiO2 ratios (partial pressure of oxygen/ fractional inspired oxygen)and MAP. In addition, NAVA has been used for patients who "fight the ventilator," and the synchrony improves the ability to wean.
The use of NIV-NAVA in neonates has promise as a primary mode of ventilation to aid in the prevention of intubation and also maintaining successful extubation. Early extubation may be enhanced with NIV-NAVA of those neonates requiring intubation for numerous reasons. The ability to provide synchronous NIV allows clinicians the opportunity to extubate infants earlier with increased confidence than with previous post extubation support.
However there is lack of scientific evidence on extubation failure rates on NI-NAVA. Trials comparing NAVA to conventional ventilators with regard to ventilator associated lung injury, ventilator associated pneumonia and decreasing duration of time on the ventilator have not yet been reported.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied|
|Official Title:||Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Infant will be extubated to NAVA, settings based per protocol
Active Comparator: NIPPV
Wait to meet extubation criteria within 14 days postnatal age
Infant will be extubated to NIPPV, settings detailed in protocol
- Extubation success [ Time Frame: 5 days ]assess how many infants stayed extubated at 5 days after extubation
- Bronchopulmonary dysplasia (BPD) [ Time Frame: until discharge / 36 weeks post menstrual age ]based on NIH guidelines
- Ventilator Days [ Time Frame: until discharge / 36 weeks post menstrual age ]days on positive pressure ventilation
- NICU length of stay [ Time Frame: until discharge / 36 weeks post menstrual age ]discharge or death or transfer
- Patent ductus arteriosus (PDA) [ Time Frame: until discharge / 36 weeks post menstrual age ]echo diagnosed/confirmed
- Necrotizing enterocolitis (NEC [ Time Frame: until discharge / 36 weeks post menstrual age ]confirmed on Xray
- Late onset sepsis [ Time Frame: until discharge / 36 weeks post menstrual age ]only culture proven
- Gastrointestinal perforation [ Time Frame: until discharge / 36 weeks post menstrual age ]confirmed on X-ray or surgical exploration
- Mortality [ Time Frame: until discharge / 36 weeks post menstrual age ]all causes within NICU stay
- Extubation failure at 3 days [ Time Frame: until discharge / 36 weeks post menstrual age ]reintubation by 72 hrs. post extubation
- Extubation failure at 7 days [ Time Frame: until discharge / 36 weeks post menstrual age ]reintubation by 72 hrs. post extubation
- Pulmonary air leak [ Time Frame: until discharge / 36 weeks post menstrual age ]including pulmonary interstitial emphysema (PIE) pneumomediastinum and pneumothorax
- Severe intraventricular hemorrhage [ Time Frame: until discharge / 36 weeks post menstrual age ]on cranial ultrasound, worst grade
- Abdominal distension > 2cm from baseline and with signs necessitating cessation of feeds during the first 48 hrs. after extubation [ Time Frame: until discharge / 36 weeks post menstrual age ]during the first 48 hrs. after extubation
- Retinopathy of prematurity (ROP) [ Time Frame: until discharge / 36 weeks post menstrual age ]ophthalmologic exam
- Ventilator associated Pneumonia (VAP) [ Time Frame: until discharge / 36 weeks post menstrual age ]diagnosed based on tracheal culture + CXR changes + clinical worsening + treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242057
|Contact: Kartikeya Makker, MDfirstname.lastname@example.org|
|Contact: Kimberly Barnetteemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Jacksonville, Florida, United States, 32207|
|Contact: Kartikeya Makker, MD 904-244-3508 firstname.lastname@example.org|
|Principal Investigator:||Kartikeya Makker, MD||University of Florida|