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Clinical Trials/NCT03868982
NCT03868982
Unknown
Not Applicable

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

Fu Jen Catholic University1 site in 1 country50 target enrollmentFebruary 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
Fu Jen Catholic University
Enrollment
50
Locations
1
Primary Endpoint
PaO2/FiO2 ratio
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 18, 2019
End Date
December 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

Eligibility Criteria

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

Outcomes

Primary Outcomes

PaO2/FiO2 ratio

Time Frame: 2 days

PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen

Secondary Outcomes

  • Tidal volume(2 days)
  • Mechanical ventilation days(3 months)
  • Length of intensive care unit stay(3 months)
  • PaCO2(2 days)
  • Length of hospital stay(3 months)

Study Sites (1)

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