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

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02043990
• Other study ID #: GCHIDINI2013
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2013
• Last updated: January 21, 2014
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2014
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Giovanna Chidini, MD
• Phone: +39-2-55032242
• Email: giovannachid[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 2 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive NAVA ventilation
Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony Index		60 minutes of each ventilatory trial, PSV or NAVA	No
Secondary	Arterial blood gases		End of each ventilatory trial	Yes