NAVA vs Standard Ventilation for Bronchiolitis
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Montefiore Medical Center
Must not be taking: Vasoactive medications
Disqualifiers: Chronic lung disease, Cyanotic heart lesions, Congestive heart failure, Hypotonia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Neurally-Adjusted Ventilatory Assistance (NAVA) for bronchiolitis?
Research shows that NAVA can improve the interaction between the patient and the ventilator, reducing delays and improving response times, which may help infants with bronchiolitis breathe more easily.
12345Is NAVA safe for use in humans?
NAVA has been shown to be safe and well tolerated in small preliminary studies with infants, including both term and preterm infants, although more research is needed before it can be widely recommended.
23678How does the treatment NAVA differ from standard ventilation for bronchiolitis?
NAVA (Neurally-Adjusted Ventilatory Assistance) is unique because it uses the electrical activity of the diaphragm to deliver breaths that are synchronized with the patient's natural breathing efforts, potentially improving comfort and effectiveness compared to standard ventilation methods.
238910Eligibility Criteria
This trial is for children under two years old diagnosed with bronchiolitis who are in the pediatric ICU. Specific details about who can't join were not provided.Inclusion Criteria
My child is under 2 years old and has severe bronchiolitis needing ICU care.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive non-invasive ventilation using either standard mode or NAVA mode for bronchiolitis treatment
4 weeks
Continuous monitoring in PICU
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares two types of non-invasive breathing support: standard ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA). It aims to see if NAVA offers better comfort and reduces the need for more intense treatments like intubation.
2Treatment groups
Experimental Treatment
Active Control
Group I: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation ArmExperimental Treatment1 Intervention
This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.
Group II: Standard Non-Invasive Mechanical Servo Ventilation ArmActive Control1 Intervention
This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital at MontefioreBronx, NY
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Who Is Running the Clinical Trial?
Montefiore Medical CenterLead Sponsor
References
Neurally adjusted ventilatory assist in ventilated very preterm infants: A crossover study. [2021]To assess the effects of neurally adjusted ventilatory assist (NAVA) ventilation on oxygenation and respiratory parameters in preterm infants.
Noninvasive Neurally Adjusted Ventilatory Assist in Infants With Bronchiolitis: Respiratory Outcomes in a Single-Center, Retrospective Cohort, 2016-2018. [2023]To describe our experience of using noninvasive neurally adjusted ventilatory assist (NIV-NAVA) in infants with bronchiolitis, its association with the evolution of respiratory effort, and PICU outcomes.
Non-invasive Neurally Adjusted Ventilatory Assist (NAVA) in the pediatric ICU: assessing optimal Edi compliance. [2021]Bronchiolitis patients are supported with non-invasive conventional modalities (HFNC, CPAP and BiPAP). Neurally Adjusted Ventilatory Assist (NAVA) is a newer mode which supports based on electrical activity of the diaphragm (Edi). It is unclear if non-invasive NAVA is used within optimal operational parameters. The study aim was to evaluate Edi compliance.
Neurally adjusted ventilator assist (NAVA) reduces asynchrony during non-invasive ventilation for severe bronchiolitis. [2022]To determine the prevalence of main inspiratory asynchrony events during non-invasive intermittent positive-pressure ventilation (NIV) for severe bronchiolitis. Ventilator response time and asynchrony were compared in neurally adjusted ventilator assist (NAVA) and in pressure assist/control (PAC) modes.
Neurally triggered breaths reduce trigger delay and improve ventilator response times in ventilated infants with bronchiolitis. [2021]Neurally adjusted ventilatory assist (NAVA) is a mode of ventilation designed to improve patient-ventilator interaction by interpreting a neural signal from the diaphragm to trigger a supported breath. We hypothesized that neurally triggered breaths would reduce trigger delay, ventilator response times, and work of breathing in pediatric patients with bronchiolitis.
Neurally adjusted ventilatory assist for rapid weaning in preterm infants. [2023]Neurally adjusted ventilatory assist (NAVA) is a new mode of subject-triggered ventilation. Experience with the use of NAVA in preterm infants is limited. This study compared the effects of invasive mechanical ventilation with NAVA to conventional intermittent mandatory ventilation (CIMV) in terms of reducing the duration of oxygen requirement and invasive ventilator support in preterm infants.
Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. [2010]Neurally adjusted ventilator assist (NAVA) is a new mode of partial ventilatory support, in which neural inspiratory activity is monitored through the continuous esophageal recording of the electrical activity of the diaphragm. Assistance is triggered and cycled off in according to this signal and is delivered in proportion to its intensity. NAVA can improve patient-ventilator synchrony while maintaining spontaneous breathing. Small preliminary studies have shown that NAVA can be successfully used also in term and preterm infants, being safe and well tolerated. However, much additional work is still needed before NAVA can be recommended in the everyday practice of the neonatologist.
Neurally adjusted ventilatory assist versus conventional ventilation in the pediatric population: Are there benefits? [2020]Neurally-adjusted ventilator assist (NAVA) is a relatively new form of ventilation in which the electrical activity of the diaphragm is sensed by a catheter. The amplitude of this electrical signal is then used to deliver an appropriately proportioned pressure supported breath to the patient. Due to the synchronous nature of the breaths and the patient-adjusted nature of the support, NAVA has been shown to have benefits over conventional ventilation. Meta-analyses were conducted of published pediatric studies to compare ventilatory endpoints between NAVA and conventional ventilation.
Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. [2018]Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient-ventilator synchrony during invasive ventilation. The aim of this trial was to study NAVA as a primary ventilation mode in pediatric intensive care and to compare it with current standard ventilation modes.
Neurally-Adjusted Ventilatory Assist Versus Pressure Support Ventilation During Noninvasive Ventilation. [2023]Noninvasive ventilation (NIV) is increasingly used during ventilatory support. Neurally-adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that can improve patient-ventilator interaction. We conducted a meta-analysis to compare patient-ventilator interaction and clinical outcomes between NAVA and pressure support ventilation (PSV) in adult subjects during NIV.