Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ARDS, Human, Mechanical Ventilation Pressure High

Intervention / Treatment
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* Device: Neurally adjusted ventilatory assist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Fifty participant with ARDS according to the Berlin Definition will enroll to this study. Participants studied twice daily with collection of data and blood tests.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVA group<br>Participent in this group will received NAVA for two days | Device: Neurally adjusted ventilatory assist<br>* NAVA uses the diaphragm activity to deliver mechanical ventilation<br>|
| No Intervention: Control group<br>Participent in this group will received standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio | PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2 | PaCO2 is a data from ABG, represent in mmHg | 2 days | 
| Tidal volume | Tidal volume is represent in ml | 2 days | 
| Mechanical ventilation days | MV days | 3 months | 
| Length of hospital stay | hospital days | 3 months | 
| Length of intensive care unit stay | ICU days | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute respiratory distress syndrome, neurally adjusted ventilatory assist, lung protective strategy