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

F

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

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

Trial contacts and locations

0

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Central trial contact

Ke-Yun Chao, M.Sc

Data sourced from clinicaltrials.gov

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