Clinical trial NCT02043990: Adjusted Ventilatory Assist (NAVA-NIV) in Infants: Short-term Physiological Study
Official title: Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: NAVA
noninvasive ventilation
infants
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Asynchrony Index
timeFrame: 60 minutes of each ventilatory trial, PSV or NAVA
Secondary outcomes:
measure: Arterial blood gases
timeFrame: End of each ventilatory trial
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
name: Giovanna Chidini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
name: Calderini Edoardo, MD
role: STUDY_CHAIR
affiliation: University Sacred Heart, Rome
name: Giorgio Conti, MD, Phd
role: STUDY_CHAIR
References:
citation: 1) Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med 2008;34:2010-2018. 2) Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med 1999;5:1433-1436. 3) Sinderby C, Beck J, Spahija J, de Marchie M, Lacroix J, Navalesi P, Slutsky AS. Inspiratory Muscle Unloading by Neurally Adjusted Ventilatory Assist during Maximal Inspiratory Efforts in Healthy Subjects. Chest 2007;131:711-717. 4) Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Non-invasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med 2008;34:316-323