NAVA Helmet in Pediatric Respiratory Failure
Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants Delivered by Helmet: a Pilot Short Term Physiological Study
1 other identifier
interventional
10
1 country
1
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), 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. Among different interfaces, the pediatric helmet is better tolerated than facial or nasal mask, thus requiring less sedation and allowing more prolonged ventilatory assistance (5-6).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) with helmet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 30, 2014
January 1, 2014
1 year
January 28, 2014
January 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asynchrony Index
60 minutes trial
Secondary Outcomes (1)
Arterial Blood Gases
end of 60 minutes ventilation trial
Study Arms (1)
Noninvasive ventilation
EXPERIMENTALNeurally Adjusted Ventilatory Assist versus Pressure Support flow triggered delivered by helmet
Interventions
Eligibility Criteria
You may qualify if:
- Infants aging \> 1 month and \< 2 years
- 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
- Reduction in airway protection
- Coma
- Contraindication to insert the nasogastric catheter
- Heart and/or lung transplant
- Increase in PIC
- Refusal of the parents or legal guardian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Related Publications (6)
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 Nov;34(11):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.
PMID: 18629471BACKGROUNDSinderby 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 Mar;131(3):711-717. doi: 10.1378/chest.06-1909.
PMID: 17356084BACKGROUNDThille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
PMID: 16896854BACKGROUNDCalderini E, Chidini G, Pelosi P. What are the current indications for noninvasive ventilation in children? Curr Opin Anaesthesiol. 2010 Jun;23(3):368-74. doi: 10.1097/ACO.0b013e328339507b.
PMID: 20440111BACKGROUNDChidini G, Calderini E, Pelosi P. Treatment of acute hypoxemic respiratory failure with continuous positive airway pressure delivered by a new pediatric helmet in comparison with a standard full face mask: a prospective pilot study. Pediatr Crit Care Med. 2010 Jul;11(4):502-8. doi: 10.1097/PCC.0b013e3181b8063b.
PMID: 19794328BACKGROUNDChidini G, Calderini E, Cesana BM, Gandini C, Prandi E, Pelosi P. Noninvasive continuous positive airway pressure in acute respiratory failure: helmet versus facial mask. Pediatrics. 2010 Aug;126(2):e330-6. doi: 10.1542/peds.2009-3357. Epub 2010 Jul 26.
PMID: 20660548BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chidini Giovanna, MD
Fondazione IRCCS Ca'Granda Policlinico
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 28, 2014
First Posted
January 30, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
January 30, 2014
Record last verified: 2014-01