NAVA vs Standard Ventilation for Bronchiolitis

Overseen By Timothy Brandt, MD

Age: < 18

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

120 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{2 3 6 7 8}

How 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. ^{2 3 8 9 10}

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.

Research Team

Jacqueline Weingarten, MD

Principal Investigator

Physician

Eligibility 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.

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

Treatment Details

Interventions

• Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation
• Standard Non-Invasive Mechanical Servo Ventilation

Trial Overview 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.

Participant Groups

Group I: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm Experimental Treatment 1 Intervention

This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.

Group II: Standard Non-Invasive Mechanical Servo Ventilation Arm Active Control 1 Intervention

This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Findings from Research

In a study of 19 preterm infants, neurally adjusted ventilatory assist (NAVA) ventilation did not increase the overall time spent within target oxygen saturation levels, but it resulted in fewer severe desaturation events and required less manual oxygen adjustment compared to conventional ventilation.

NAVA ventilation also led to lower electrical activity of the diaphragm and reduced peak inspiratory pressures, suggesting it may provide a gentler approach to respiratory support for very preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist in ventilated very preterm infants: A crossover study. Oda, A., Parikka, V., Lehtonen, L., et al.[2021]

In a study of 64 infants with bronchiolitis who failed initial noninvasive support, the use of noninvasive neurally adjusted ventilatory assist (NIV-NAVA) led to a significant reduction in respiratory effort, as indicated by a decrease in the modified Wood Clinical Asthma Score (mWCAS) and electrical diaphragmatic activity (Edi).

The overall intubation rate for patients treated with NIV-NAVA was low at 9%, suggesting that NIV-NAVA can be a safe and effective option for managing respiratory distress in infants with bronchiolitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Neurally Adjusted Ventilatory Assist in Infants With Bronchiolitis: Respiratory Outcomes in a Single-Center, Retrospective Cohort, 2016-2018. Lepage-Farrell, A., Tabone, L., Plante, V., et al.[2023]

In a study of 63 bronchiolitis patients, non-invasive Neurally Adjusted Ventilatory Assist (NAVA) showed suboptimal compliance with operational parameters, with only 50.4% of patients meeting the ideal diaphragm electrical activity levels.

Patients on NAVA had significantly longer stays in the PICU and took more time to reach minimal respiratory support compared to those on conventional non-NAVA support, suggesting that while NAVA is a newer technology, it may not yet be as effective in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Neurally Adjusted Ventilatory Assist (NAVA) in the pediatric ICU: assessing optimal Edi compliance. Lamsal, R., Fischer, G., Shyne, M., et al.[2021]

In a study of 11 infants with severe bronchiolitis, the use of neurally adjusted ventilator assist (NAVA) mode significantly reduced patient-ventilator inspiratory asynchronies compared to pressure assist/control (PAC) mode, with an asynchrony index of 3% in NAVA versus 38% in PAC.

NAVA mode also resulted in a shorter trigger delay (44 ms) and fewer ineffective breathing efforts (0.54 events/min) compared to PAC mode (116 ms and 21.8 events/min), indicating improved synchronization and potentially better ventilation for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilator assist (NAVA) reduces asynchrony during non-invasive ventilation for severe bronchiolitis. Baudin, F., Pouyau, R., Cour-Andlauer, F., et al.[2022]

Neurally adjusted ventilatory assist (NAVA) significantly reduces trigger delay and ventilator response times in pediatric patients with bronchiolitis, leading to quicker and more efficient breaths compared to traditional pneumatic triggers.

The use of NAVA also decreases the work of breathing, as indicated by lower pressure-time product measurements, suggesting it may enhance patient comfort and efficiency during ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally triggered breaths reduce trigger delay and improve ventilator response times in ventilated infants with bronchiolitis. Clement, KC., Thurman, TL., Holt, SJ., et al.[2021]

In a study involving 53 preterm infants (26 on NAVA and 27 on CIMV), those on Neurally Adjusted Ventilatory Assist (NAVA) required significantly less supplemental oxygen at 28 days of age (46% vs. 78%) and fewer days of invasive ventilator support (7.73 days vs. 17.26 days).

NAVA may facilitate quicker weaning from invasive ventilation and reduce the risk of bronchopulmonary dysplasia in preterm infants with severe respiratory distress syndrome, suggesting it could be a safer and more effective option compared to conventional intermittent mandatory ventilation (CIMV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist for rapid weaning in preterm infants. Fang, SJ., Su, CH., Liao, DL., et al.[2023]

NAVA (Neurally Adjusted Ventilator Assist) is a new ventilatory support method that enhances patient-ventilator synchrony by monitoring the diaphragm's electrical activity, allowing for more responsive breathing assistance.

Preliminary studies indicate that NAVA is safe and well tolerated in both term and preterm infants, but further research is necessary before it can be widely recommended for routine use in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. Biban, P., Serra, A., Polese, G., et al.[2010]

NAVA (Neurally-adjusted ventilator assist) showed a 17% reduction in asynchrony and a 1.74 cmH2O lower peak inspiratory pressure (PIP) compared to conventional ventilation in pediatric patients, indicating improved synchronization and potentially less respiratory effort.

Oxygen saturation was also 1.1% higher with NAVA, suggesting better oxygen delivery, although other measured parameters did not show clinically significant differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist versus conventional ventilation in the pediatric population: Are there benefits? Karikari, S., Rausa, J., Flores, S., et al.[2020]

In a study involving 170 pediatric intensive care patients, Neurally Adjusted Ventilatory Assist (NAVA) was found to be a safe and effective primary ventilation mode, showing a trend towards shorter ventilator time (3.3 hours for NAVA vs. 6.6 hours for conventional ventilation) and reduced length of stay in the PICU (49.5 hours vs. 72.8 hours).

NAVA also demonstrated a significant reduction in the amount of sedation required for patients, particularly when excluding postoperative cases, indicating that it may enhance patient comfort and reduce medication use during ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. Kallio, M., Peltoniemi, O., Anttila, E., et al.[2018]

Neurally-adjusted ventilatory assist (NAVA) significantly improves patient-ventilator interaction compared to pressure support ventilation (PSV), as evidenced by a lower asynchrony index (AI) in 615 adult subjects across 15 studies.

While NAVA shows better interaction metrics, it is associated with longer ICU stays and higher discomfort levels compared to PSV, indicating a need for further research on its overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally-Adjusted Ventilatory Assist Versus Pressure Support Ventilation During Noninvasive Ventilation. Weiyun, T., Linli, S., Liuzhao, C.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist in ventilated very preterm infants: A crossover study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Neurally Adjusted Ventilatory Assist in Infants With Bronchiolitis: Respiratory Outcomes in a Single-Center, Retrospective Cohort, 2016-2018. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Non-invasive Neurally Adjusted Ventilatory Assist (NAVA) in the pediatric ICU: assessing optimal Edi compliance. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilator assist (NAVA) reduces asynchrony during non-invasive ventilation for severe bronchiolitis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Neurally triggered breaths reduce trigger delay and improve ventilator response times in ventilated infants with bronchiolitis. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist for rapid weaning in preterm infants. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist versus conventional ventilation in the pediatric population: Are there benefits? [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Neurally-Adjusted Ventilatory Assist Versus Pressure Support Ventilation During Noninvasive Ventilation. [2023]