NCT02043990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

April 28, 2013

Last Update Submit

January 21, 2014

Conditions

Acute Respiratory Failure

Keywords

NAVAnoninvasive ventilationinfants

Outcome Measures

Primary Outcomes (1)

  • Asynchrony Index

    60 minutes of each ventilatory trial, PSV or NAVA

Secondary Outcomes (1)

  • Arterial blood gases

    End of each ventilatory trial

Study Arms (1)

Noninvasive NAVA Ventilation

EXPERIMENTAL

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Device: Noninvasive NAVA ventilation

Interventions

Noninvasive NAVA ventilationDEVICE

Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation

Noninvasive NAVA Ventilation

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related 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

    BACKGROUND

Study Officials

  • Giovanna Chidini, MD

    Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

  • Calderini Edoardo, MD

    Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    STUDY CHAIR

  • Giorgio Conti, MD, Phd

    University Sacred Heart, Rome

    STUDY CHAIR

Central Study Contacts

Giovanna Chidini, MD

CONTACT

+39-2-55032242giovannachid@libero.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2013

First Posted

January 23, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

IT(1)