Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist (NAVA)

Fu Jen Catholic University

Status: Enrolling

Conditions: Mechanical Ventilation Pressure High; ARDS, Human

Treatments: Device: Neurally adjusted ventilatory assist

Study type: Interventional

Funder types: Other

Identifiers

NCT03868982

PL-201808006-V

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ARDS by Berlin definition
• P/F ratio between 100-300
• Completed the case enrollement within 48 hours

Exclusion criteria

• Less than 18 years old
• Pregnancy
• Participants with tracheostomy
• Unable to insert the NG-tube

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

NAVA group

Experimental group

Description:

Participent in this group will received NAVA for two days

Treatment:

Device: Neurally adjusted ventilatory assist

Control group

No Intervention group

Description:

Participent in this group will received standard care