Lung Protection in ARDS Using Neurally Adjusted Ventilato... | NCT03868982

Studies
Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist

NCT03868982

Sponsor

Fu Jen Catholic University

Status

Unknown status

Last Update Posted

Oct 26, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

ARDS, Human
Mechanical Ventilation Pressure High

Interventions

Neurally adjusted ventilatory assist

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2019Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Mar 4, 2019

First Submission Date that Met QC Criteria

Mar 8, 2019

First Posted Date

Mar 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2022

Last Update Posted Date

Oct 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic UniversityPrincipal Investigator

Lead Sponsor

Fu Jen Catholic UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAVA group	Experimental	Participent in this group will received NAVA for two days	Device: Neurally adjusted ventilatory assist
Control group	No Intervention	Participent in this group will received standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurally adjusted ventilatory assist	Device	NAVA uses the diaphragm activity to deliver mechanical ventilation	NAVA group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ke-Yun Chao, M.Sc	Contact	+886952909103		ck_qq@hotmail.com

Overall Officials

Name	Affiliation	Role
Wen-Lun Liu, MD	Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fu Jen Catholic University Hospital, Fu Jen Catholic University	Recruiting	New Taipei City		24352	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20395897	Background	Navalesi P, Colombo D, Della Corte F. NAVA ventilation. Minerva Anestesiol. 2010 May;76(5):346-52.
30820583	Background	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.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy