ARDS, Human, Mechanical Ventilation Pressure High
Conditions
Keywords
acute respiratory distress syndrome, neurally adjusted ventilatory assist, lung protective strategy
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.
Interventions
NAVA uses the diaphragm activity to deliver mechanical ventilation
Sponsors
Fu Jen Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be randomized into study group or control group, and which is single blind processes to participants.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2/FiO2 ratio | 2 days | PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PaCO2 | 2 days | PaCO2 is a data from ABG, represent in mmHg |
| Tidal volume | 2 days | Tidal volume is represent in ml |
| Mechanical ventilation days | 3 months | MV days |
| Length of hospital stay | 3 months | hospital days |
| Length of intensive care unit stay | 3 months | ICU days |
Countries
Taiwan
Contacts
Primary ContactKe-Yun Chao, M.Sc
Outcome results
None listed