Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist (NAVA)
Primary Purpose
ARDS, Human, Mechanical Ventilation Pressure High
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Neurally adjusted ventilatory assist
Sponsored by
About this trial
This is an interventional treatment trial for ARDS, Human focused on measuring 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
Sites / Locations
- Fu Jen Catholic University Hospital, Fu Jen Catholic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NAVA group
Control group
Arm Description
Participent in this group will received NAVA for two days
Participent in this group will received standard care
Outcomes
Primary Outcome Measures
PaO2/FiO2 ratio
PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen
Secondary Outcome Measures
PaCO2
PaCO2 is a data from ABG, represent in mmHg
Tidal volume
Tidal volume is represent in ml
Mechanical ventilation days
MV days
Length of hospital stay
hospital days
Length of intensive care unit stay
ICU days
Full Information
NCT ID
NCT03868982
First Posted
March 4, 2019
Last Updated
October 24, 2022
Sponsor
Fu Jen Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT03868982
Brief Title
Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist
Acronym
NAVA
Official Title
Lung Protection in Acute Respiratory Distress Syndrome Using Neurally Adjusted Ventilatory Assist
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human, Mechanical Ventilation Pressure High
Keywords
acute respiratory distress syndrome, neurally adjusted ventilatory assist, lung protective strategy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participants will be randomized into study group or control group, and which is single blind processes to participants.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAVA group
Arm Type
Experimental
Arm Description
Participent in this group will received NAVA for two days
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participent in this group will received standard care
Intervention Type
Device
Intervention Name(s)
Neurally adjusted ventilatory assist
Intervention Description
NAVA uses the diaphragm activity to deliver mechanical ventilation
Primary Outcome Measure Information:
Title
PaO2/FiO2 ratio
Description
PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen
Time Frame
2 days
Secondary Outcome Measure Information:
Title
PaCO2
Description
PaCO2 is a data from ABG, represent in mmHg
Time Frame
2 days
Title
Tidal volume
Description
Tidal volume is represent in ml
Time Frame
2 days
Title
Mechanical ventilation days
Description
MV days
Time Frame
3 months
Title
Length of hospital stay
Description
hospital days
Time Frame
3 months
Title
Length of intensive care unit stay
Description
ICU days
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke-Yun Chao, M.Sc
Phone
+886952909103
Email
ck_qq@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Lun Liu, MD
Organizational Affiliation
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fu Jen Catholic University Hospital, Fu Jen Catholic University
City
New Taipei City
ZIP/Postal Code
24352
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, M.Sc
Phone
+886952909103
Email
ck_qq@hotmail.con
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, M.Sc
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20395897
Citation
Navalesi P, Colombo D, Della Corte F. NAVA ventilation. Minerva Anestesiol. 2010 May;76(5):346-52.
Results Reference
background
PubMed Identifier
30820583
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.
Results Reference
background
PubMed Identifier
30610519
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.
Results Reference
background
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Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist
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