NCT03868982

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 26, 2022

Status Verified

February 1, 2022

Enrollment Period

4.4 years

First QC Date

March 4, 2019

Last Update Submit

October 24, 2022

Conditions

ARDS, HumanMechanical Ventilation Pressure High

Keywords

acute respiratory distress syndromeneurally adjusted ventilatory assistlung protective strategy

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio

    PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen

    2 days

Secondary Outcomes (5)

  • PaCO2

    2 days

  • Tidal volume

    2 days

  • Mechanical ventilation days

    3 months

  • Length of hospital stay

    3 months

  • Length of intensive care unit stay

    3 months

Study Arms (2)

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

Neurally adjusted ventilatory assistDEVICE

NAVA uses the diaphragm activity to deliver mechanical ventilation

NAVA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ARDS by Berlin definition
  • P/F ratio between 100-300
  • Completed the case enrollement within 48 hours

You may not qualify if:

  • Less than 18 years old
  • Pregnancy
  • Participants with tracheostomy
  • Unable to insert the NG-tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

Related Publications (3)

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

    PMID: 20395897BACKGROUND

  • 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.

    PMID: 30820583BACKGROUND

  • 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.

    PMID: 30610519BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Wen-Lun Liu, MD

    Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, M.Sc

CONTACT

+886952909103ck_qq@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomized into study group or control group, and which is single blind processes to participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 11, 2019

Study Start

February 18, 2019

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

October 26, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)