Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist (NAVA)

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

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).

Study Overview

• Status: Recruiting
• Conditions: ARDS, Human; Mechanical Ventilation Pressure High
• Intervention / Treatment: Device: Neurally adjusted ventilatory assist

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke-Yun Chao, M.Sc; Phone Number: +886952909103; Email: ck_qq@hotmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Recruiting
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    • Contact: Ke-Yun Chao, M.Sc; Phone Number: +886952909103; Email: ck_qq@hotmail.con
    • Principal Investigator: Ke-Yun Chao, M.Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 ratio	PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2	PaCO2 is a data from ABG, represent in mmHg	2 days
Tidal volume	Tidal volume is represent in ml	2 days
Mechanical ventilation days	MV days	3 months
Length of hospital stay	hospital days	3 months
Length of intensive care unit stay	ICU days	3 months

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Wen-Lun Liu, MD, Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: acute respiratory distress syndrome; lung protective strategy; neurally adjusted ventilatory assist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: PL-201808006-V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No