Clinical trial NCT03868982: Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist
Official title: Lung Protection in Acute Respiratory Distress Syndrome Using Neurally Adjusted Ventilatory Assist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS, Human
Mechanical Ventilation Pressure High
Keywords: acute respiratory distress syndrome
neurally adjusted ventilatory assist
lung protective strategy
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 2 days
Secondary outcomes:
measure: PaCO2
timeFrame: 2 days
measure: Tidal volume
timeFrame: 2 days
measure: Mechanical ventilation days
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: 3 months
measure: Length of intensive care unit stay
timeFrame: 3 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University
name: Wen-Lun Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navalesi P, Colombo D, Della Corte F. NAVA ventilation. Minerva Anestesiol. 2010 May;76(5):346-52.
citation: 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.
citation: 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.