Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Optimisation of Neonatal Ventilation - NAVA vs PAV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967549
• Other study ID #: KCH16-150
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Born at less than 32 weeks gestation
• ventilated at or beyond one week of life

Exclusion Criteria:

• major congenital abnormalities

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Device:
• NAVA
NAVA delivered by the Servo-n ventilator (Maquet)
• PAV
PAV delivered by the Stephanie ventilator (Stephan)

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation index	Oxygenation index at the end of each period of ventilation	2 hours