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

Primary Purpose

Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Noninvasive NAVA ventilation
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring NAVA, noninvasive ventilation, infants

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Noninvasive NAVA Ventilation

Arm Description

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Outcomes

Primary Outcome Measures

Asynchrony Index

Secondary Outcome Measures

Arterial blood gases

Full Information

First Posted
April 28, 2013
Last Updated
January 21, 2014
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT02043990
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
NAVA, noninvasive ventilation, infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noninvasive NAVA Ventilation
Arm Type
Experimental
Arm Description
Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation
Intervention Type
Device
Intervention Name(s)
Noninvasive NAVA ventilation
Intervention Description
Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation
Primary Outcome Measure Information:
Title
Asynchrony Index
Time Frame
60 minutes of each ventilatory trial, PSV or NAVA
Secondary Outcome Measure Information:
Title
Arterial blood gases
Time Frame
End of each ventilatory trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanna Chidini, MD
Phone
+39-2-55032242
Email
giovannachid@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Chidini, MD
Organizational Affiliation
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Calderini Edoardo, MD
Organizational Affiliation
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giorgio Conti, MD, Phd
Organizational Affiliation
University Sacred Heart, Rome
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Chidini, MD

12. IPD Sharing Statement

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

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