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

NCT ID: NCT02043990

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-05-31

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).

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Noninvasive NAVA Ventilation

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Group Type: EXPERIMENTAL

Noninvasive NAVA ventilation

Intervention Type: DEVICE

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Interventions

Noninvasive NAVA ventilation

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanna Chidini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Calderini Edoardo, MD

Role: STUDY_CHAIR

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Giorgio Conti, MD, Phd

Role: STUDY_CHAIR

University Sacred Heart, Rome

Locations

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanna Chidini, MD

Role: CONTACT

giovannachid@libero.it

+39-2-55032242

References

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

Reference Type: BACKGROUND

Other Identifiers

GCHIDINI2013

Identifier Type: -

Identifier Source: org_study_id