Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist

ARDS, Human Clinical Trial

— NAVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868982
• Other study ID #: PL-201808006-V
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2022
• Source: Fu Jen Catholic University
• Contact: Ke-Yun Chao, M.Sc
• Phone: +886952909103
• Email: ck_qq[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• Mechanical Ventilation Pressure High
• Respiratory Distress Syndrome

Intervention

Device:
• Neurally adjusted ventilatory assist
NAVA uses the diaphragm activity to deliver mechanical ventilation

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. — View Citation

Navalesi P, Colombo D, Della Corte F. NAVA ventilation. Minerva Anestesiol. 2010 May;76(5):346-52. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen	2 days
Secondary	PaCO2	PaCO2 is a data from ABG, represent in mmHg	2 days
Secondary	Tidal volume	Tidal volume is represent in ml	2 days
Secondary	Mechanical ventilation days	MV days	3 months
Secondary	Length of hospital stay	hospital days	3 months
Secondary	Length of intensive care unit stay	ICU days	3 months