NCT03868982

Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist

Lung Protection in Acute Respiratory Distress Syndrome Using Neurally Adjusted Ventilatory Assist

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fu Jen Catholic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the use neurally adjusted ventilatory assist (NAVA) as lung protective strategy in patients with acute respiratory distress syndrome (ARDS).

Detailed description

Background： Acute respiratory distress syndrome (ARDS) should ventilated with a tidal volume of 4-6 ml/kg according to the ARDSnet recommendations. Due to the lack of clinical evidence of the potential role of neurally adjusted ventilatory assist (NAVA) in ARDS, investigators would like to conduct a study comparing the two modes from a lung protective point of view. Investigators believe it may have a great value in defining guidelines for improved lung protection. Study Design： This is a prospective, pilot-randomized controlled trial n a single intensive care unit from one hospital. The study is expected to close the case a year (2018.08.01-2019.07.31). Methods： Fifty patients with ARDS according to the Berlin Definition will enroll to this study. Patients are randomized after fulfilling inclusion and none of the exclusion criteria (25 participants will divide into study group and the other 25 participants will be control group). Patients are studied twice daily with collection of data and blood tests. All data are collected and analysis. Effect： Tidal volumes in ARDS patients ventilated with NAVA will show tidal volumes clearly within the safe range. ARDS patients on NAVA mode will show improvements in oxygenation, gas distribution and inflammatory markers while requiring less sedatives and hemodynamic support. Key words： Acute respiratory distress syndrome; neurally adjusted ventilatory assist; lung protective strategy.

Conditions

• ARDS, Human
• Mechanical Ventilation Pressure High

Interventions

Type	Name	Description
DEVICE	Neurally adjusted ventilatory assist	NAVA uses the diaphragm activity to deliver mechanical ventilation

Timeline

• Start date: 2019-02-18
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2019-03-11
• Last updated: 2022-10-26

Locations

1 site across 1 country: Taiwan