Brief Title
Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation
Official Title
Optimisation of Neonatal Ventilation - NAVA vs PAV
Brief Summary
This study aims to assess whether neurally adjusted ventilatory assist or proportional assist
ventilation is more effective in infants born prematurely with evolving or established
bronchopulmonary dysplasia
Detailed Description
Despite improvements in survival rates of extremely preterm born infants, the incidence of
bronchopulmonary dysplasia (BPD) remains unchanged over the last two decades. As invasive
ventilation is frequently necessary and indeed life saving, numerous ventilator strategies
have been developed to reduce damage to the developing lung. Synchronisation of mechanical
breaths with the patient's respiratory effort offers the theoretical benefit of improving
oxygenation and ventilation, requiring lower ventilator pressures, fewer air leaks and
increased patient comfort.
Recently, novel modes of ventilation have been introduced that aim to improve upon
conventional ventilation. During both proportional assist ventilation (PAV) and
neurally-adjusted ventilatory assist (NAVA), respiratory support is servo-controlled based on
continuous input from the baby's respiratory effort. Both aim to improve synchronization of
the timing of the respiratory cycle and also to vary the level of support offered
breath-to-breath in proportion to the respiratory effort of the patient.
During proportional assist ventilation (PAV), the ventilator can vary inflation pressure in
phase with both volume change and flow change in order to offload both elastic and resistive
components of the work of breathing. We have previously shown that PAV, compared to ACV,
reduces the oxygenation index and improves respiratory muscle strength in infants born
prematurely who remain ventilated at or beyond one week of life .
Neurally adjusted ventilatory assist (NAVA) utilises the electrical activity of the diaphragm
to trigger the ventilator. A modified nasogastric feeding tube with a series of electrodes
allows monitoring of the diaphragmatic electromyogram (Edi). The waveform of the Edi is used
to trigger and control ventilator support. We have recently shown that NAVA compared to ACV
results in a lower oxygenation index in infants born prematurely who remain ventilated at or
beyond one week of life.
Both PAV and NAVA have been shown to have advantages above conventional triggered ventilation
in neonates, but they have not been compared to each other. Our aim is to determine whether
NAVA or PAV is more effective in prematurely born neonates with evolving or established BPD.
Study Type
Interventional
Primary Outcome
Oxygenation index
Condition
Bronchopulmonary Dysplasia
Intervention
NAVA
Study Arms / Comparison Groups
NAVA then PAV
Description: Infants randomised to NAVA then PAV
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
18
Start Date
November 2016
Completion Date
August 2018
Primary Completion Date
August 2018
Eligibility Criteria
Inclusion Criteria:
- Born at less than 32 weeks gestation
- ventilated at or beyond one week of life
Exclusion Criteria:
- major congenital abnormalities
Gender
All
Ages
1 Week - 1 Year
Accepts Healthy Volunteers
No
Contacts
Anne Greenough, MD, FRCPCH, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02967549
Organization ID
KCH16-150
Responsible Party
Sponsor
Study Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
Study Sponsor
Anne Greenough, MD, FRCPCH, Study Director, King's College London
Verification Date
March 2018