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Adjusted Ventilatory Assist (NAVA-NIV) in Infants: Short-term Physiological Study

Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02043990
Enrollment
15
Registered
2014-01-23
Start date
2013-03-31
Completion date
2014-05-31
Last updated
2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

NAVA, noninvasive ventilation, infants

Brief summary

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with Acute Respiratory Failure.

Detailed description

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the Electrical Activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. A high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation. NAVA has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients. Moreover NAVA was found to be effective in delivering non-invasive ventilation (NIV) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure. With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV).

Interventions

DEVICENoninvasive NAVA ventilation

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No

Inclusion criteria

* Infants aging \> 1 month and \< 2 yrs * ARF (PaO2/FiO2 \< 300 mmHg) * Accessory muscle recruitment * Respiratory Rate more than 2 SD related to age * Intact neuromuscular pathway to the diaphragm

Exclusion criteria

* Hemodynamic instability * Facial Surgery * Reduction in airway protection * Coma * Contraindication to insert the nasogastric catheter * Heart and lung transplant * Increase in PIC * Refusal of the parents or legal guardian * Enrolment in other research protocols

Design outcomes

Primary

MeasureTime frame
Asynchrony Index60 minutes of each ventilatory trial, PSV or NAVA

Secondary

MeasureTime frame
Arterial blood gasesEnd of each ventilatory trial

Countries

Italy

Contacts

Primary ContactGiovanna Chidini, MD
giovannachid@libero.it+39-2-55032242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026