Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist

Not Applicable

• Conditions: Mechanical Ventilation Pressure High; ARDS, Human
• Interventions: Device: Neurally adjusted ventilatory assist

• Registration Number: NCT03868982
• Lead Sponsor: Fu Jen Catholic University

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.

Study Timeline

• Study Start: 2019-02-18
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAVA group	Neurally adjusted ventilatory assist	Participent in this group will received NAVA for two days

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio	2 days	PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen

Secondary Outcome Measures

Name	Time	Method
Tidal volume	2 days	Tidal volume is represent in ml
Mechanical ventilation days	3 months	MV days
Length of intensive care unit stay	3 months	ICU days
PaCO2	2 days	PaCO2 is a data from ABG, represent in mmHg
Length of hospital stay	3 months	hospital days

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan