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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868982
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ke-Yun, Chao, Fu Jen Catholic University

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).

Condition or disease Intervention/treatment Phase
ARDS, Human Mechanical Ventilation Pressure High Device: Neurally adjusted ventilatory assist Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Masking Description: Participants will be randomized into study group or control group, and which is single blind processes to participants.
Primary Purpose: Treatment
Official Title: Lung Protection in Acute Respiratory Distress Syndrome Using Neurally Adjusted Ventilatory Assist
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


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



Primary Outcome Measures :
  1. PaO2/FiO2 ratio [ Time Frame: 2 days ]
    PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen


Secondary Outcome Measures :
  1. PaCO2 [ Time Frame: 2 days ]
    PaCO2 is a data from ABG, represent in mmHg

  2. Tidal volume [ Time Frame: 2 days ]
    Tidal volume is represent in ml

  3. Mechanical ventilation days [ Time Frame: 3 months ]
    MV days

  4. Length of hospital stay [ Time Frame: 3 months ]
    hospital days

  5. Length of intensive care unit stay [ Time Frame: 3 months ]
    ICU days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868982


Contacts
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Contact: Ke-Yun Chao, M.Sc +886952909103 ck_qq@hotmail.com

Locations
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Taiwan
Fu Jen Catholic University Hospital, Fu Jen Catholic University Recruiting
New Taipei City, Taiwan, 24352
Contact: Ke-Yun Chao, M.Sc    +886952909103    ck_qq@hotmail.con   
Principal Investigator: Ke-Yun Chao, M.Sc         
Sponsors and Collaborators
Fu Jen Catholic University
Investigators
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Principal Investigator: Wen-Lun Liu, MD Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital, Fu Jen Catholic University
Publications:
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Responsible Party: Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University
ClinicalTrials.gov Identifier: NCT03868982    
Other Study ID Numbers: PL-201808006-V
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ke-Yun, Chao, Fu Jen Catholic University:
acute respiratory distress syndrome
neurally adjusted ventilatory assist
lung protective strategy
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders