Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist (NAVA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03868982|
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|ARDS, Human Mechanical Ventilation Pressure High||Device: Neurally adjusted ventilatory assist||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking Description:||Participants will be randomized into study group or control group, and which is single blind processes to participants.|
|Official Title:||Lung Protection in Acute Respiratory Distress Syndrome Using Neurally Adjusted Ventilatory Assist|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: NAVA group
Participent in this group will received NAVA for two days
Device: Neurally adjusted ventilatory assist
NAVA uses the diaphragm activity to deliver mechanical ventilation
No Intervention: Control group
Participent in this group will received standard care
- PaO2/FiO2 ratio [ Time Frame: 2 days ]PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen
- PaCO2 [ Time Frame: 2 days ]PaCO2 is a data from ABG, represent in mmHg
- Tidal volume [ Time Frame: 2 days ]Tidal volume is represent in ml
- Mechanical ventilation days [ Time Frame: 3 months ]MV days
- Length of hospital stay [ Time Frame: 3 months ]hospital days
- Length of intensive care unit stay [ Time Frame: 3 months ]ICU days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868982
|Contact: Ke-Yun Chao, M.Scemail@example.com|
|Fu Jen Catholic University Hospital, Fu Jen Catholic University||Recruiting|
|New Taipei City, Taiwan, 24352|
|Contact: Ke-Yun Chao, M.Sc +886952909103 firstname.lastname@example.org|
|Principal Investigator: Ke-Yun Chao, M.Sc|
|Principal Investigator:||Wen-Lun Liu, MD||Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University|