Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation
Primary Purpose
Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NAVA
PAV
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia
Eligibility Criteria
Inclusion Criteria:
- Born at less than 32 weeks gestation
- ventilated at or beyond one week of life
Exclusion Criteria:
- major congenital abnormalities
Sites / Locations
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NAVA then PAV
PAV then NAVA
Arm Description
Infants randomised to NAVA then PAV
Infants randomised to PAV then NAVA
Outcomes
Primary Outcome Measures
Oxygenation index
Oxygenation index at the end of each period of ventilation
Secondary Outcome Measures
Full Information
NCT ID
NCT02967549
First Posted
November 15, 2016
Last Updated
September 15, 2021
Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02967549
Brief Title
Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation
Official Title
Optimisation of Neonatal Ventilation - NAVA vs PAV
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAVA then PAV
Arm Type
Experimental
Arm Description
Infants randomised to NAVA then PAV
Arm Title
PAV then NAVA
Arm Type
Experimental
Arm Description
Infants randomised to PAV then NAVA
Intervention Type
Device
Intervention Name(s)
NAVA
Other Intervention Name(s)
neurally adjusted ventilatory assist
Intervention Description
NAVA delivered by the Servo-n ventilator (Maquet)
Intervention Type
Device
Intervention Name(s)
PAV
Other Intervention Name(s)
Proportional Assist Ventilation
Intervention Description
PAV delivered by the Stephanie ventilator (Stephan)
Primary Outcome Measure Information:
Title
Oxygenation index
Description
Oxygenation index at the end of each period of ventilation
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Born at less than 32 weeks gestation
ventilated at or beyond one week of life
Exclusion Criteria:
major congenital abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Greenough, MD, FRCPCH
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31980954
Citation
Hunt KA, Dassios T, Greenough A. Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. Eur J Pediatr. 2020 Jun;179(6):901-908. doi: 10.1007/s00431-020-03584-w. Epub 2020 Jan 25.
Results Reference
background
Learn more about this trial
Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation
We'll reach out to this number within 24 hrs