Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist
NCT ID: NCT03868982
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-02-18
2023-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NAVA group
Participent in this group will received NAVA for two days
Neurally adjusted ventilatory assist
NAVA uses the diaphragm activity to deliver mechanical ventilation
Control group
Participent in this group will received standard care
No interventions assigned to this group
Interventions
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Neurally adjusted ventilatory assist
NAVA uses the diaphragm activity to deliver mechanical ventilation
Eligibility Criteria
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Inclusion Criteria
* P/F ratio between 100-300
* Completed the case enrollement within 48 hours
Exclusion Criteria
* Pregnancy
* Participants with tracheostomy
* Unable to insert the NG-tube
18 Years
ALL
No
Sponsors
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Fu Jen Catholic University
OTHER
Responsible Party
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Ke-Yun, Chao
Group leader of Respiratory Therapists
Principal Investigators
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Wen-Lun Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University
Locations
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Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Navalesi P, Colombo D, Della Corte F. NAVA ventilation. Minerva Anestesiol. 2010 May;76(5):346-52.
Bourenne J, Guervilly C, Mechati M, Hraiech S, Fraisse M, Bisbal M, Roch A, Forel JM, Papazian L, Gainnier M. Variability of reverse triggering in deeply sedated ARDS patients. Intensive Care Med. 2019 May;45(5):725-726. doi: 10.1007/s00134-018-5500-6. Epub 2019 Feb 28. No abstract available.
Assy J, Mauriat P, Tafer N, Soulier S, El Rassi I. Neurally adjusted ventilatory assist for children on veno-venous ECMO. J Artif Organs. 2019 Jun;22(2):118-125. doi: 10.1007/s10047-018-01087-y. Epub 2019 Jan 4.
Other Identifiers
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PL-201808006-V
Identifier Type: -
Identifier Source: org_study_id
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