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Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?

Primary Purpose

Obstructive Lung Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ventilator mode
Sponsored by
Fu Jen Catholic University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Lung Diseases focused on measuring Neurally Adjusted Ventilatory Assist, ventilator-free days, patient-ventilator synchrony, diaphragm atrophy, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Obstructive pulmonary diseases include chronic obstructive pulmonary disease (COPD), asthma (Asthma), cystic fibrosis (cystic fibrosis), bronchiectasis (bronchiectasis), bronchiolitis or other diseases that cause airway stenosis, etc.
  2. Other patients with obstructive pulmonary disease assessed by the clinical team
  3. Consent signed by the principal or legal representative
  4. Age > 20 years old and < 99 years old

Exclusion Criteria:

  1. Those who cannot place a nasogastric tube due to medical conditions
  2. Pregnant women
  3. Those who have received gas cutting
  4. Patients with phrenic nerve palsy
  5. Neuromuscular disease
  6. Intubation due to cardiac arrest

Sites / Locations

  • Fu Jen Catholic University Hospital All Rights ReservedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional group

experimental group

Arm Description

Using conventional mode to compare mechanical ventilation day with experimental group

Using neurally adjusted ventilatory assist mode to compare mechanical ventilation day with conventional group

Outcomes

Primary Outcome Measures

ventilator-free days(VFDs)
Each day during the measurement period that participants are both alive and free of mechanical ventilation. A participants who is extubated on Day 2 of the study and remains alive and free of the ventilator for the remainder of the 28-day study period.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2022
Last Updated
October 23, 2022
Sponsor
Fu Jen Catholic University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05595733
Brief Title
Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?
Official Title
Can Neurally Adjusted Ventilatory Assist Mode Reduce Mechanical Ventilation Day in Patients With Chronic Obstructive Pulmonary Disease ?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fu Jen Catholic University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Neurally Adjusted Ventilatory Assist (NAVA) mode is a new mode of ventilator, using electronic potential of diaphragm to adjust tidal volume. At the same time, this mode can trigger and cycle-off inspiratory time by high sensitivity of electronic potential of diaphragm, increase patient-ventilator synchrony, reduce sedative drug, improve oxygenation, shorten mechanical ventilation day and reduce the rate of diaphragm atrophy. It can improve survival rate and hospital day of patients. Both the animal and human experiment have the effect of lung and diaphragm protection Effect: The results of this trial are expected to obtain electronic potential of diaphragm in patients with obstructive pulmonary disease. Reviewing the current literature, few related literatures have such data presentation. This trial hopes to evaluate whether the use of NAVA can reduce mechanical ventilation day by analyzing electronic potential of diaphragm in patients with obstructive pulmonary disease. Investigators expect that participants with obstructive pulmonary disease using NAVA mode will have significantly less mechanical ventilation day than using conventional mode

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Lung Diseases
Keywords
Neurally Adjusted Ventilatory Assist, ventilator-free days, patient-ventilator synchrony, diaphragm atrophy, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional group
Arm Type
No Intervention
Arm Description
Using conventional mode to compare mechanical ventilation day with experimental group
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Using neurally adjusted ventilatory assist mode to compare mechanical ventilation day with conventional group
Intervention Type
Device
Intervention Name(s)
Ventilator mode
Intervention Description
Neurally Adjusted Ventilatory Assist (NAVA) mode is a new mode of ventilator, using electronic potential of diaphragm to adjust tidal volume. At the same time, this mode can trigger and cycle-off inspiratory time by high sensitivity of electronic potential of diaphragm, increase patient-ventilator synchrony, reduce sedative drug, improve oxygenation, shorten mechanical ventilation day and reduce the rate of diaphragm atrophy. It can improve survival rate and hospital day of patients. Both the animal and human experiment have the effect of lung and diaphragm protection.
Primary Outcome Measure Information:
Title
ventilator-free days(VFDs)
Description
Each day during the measurement period that participants are both alive and free of mechanical ventilation. A participants who is extubated on Day 2 of the study and remains alive and free of the ventilator for the remainder of the 28-day study period.
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obstructive pulmonary diseases include chronic obstructive pulmonary disease (COPD), asthma (Asthma), cystic fibrosis (cystic fibrosis), bronchiectasis (bronchiectasis), bronchiolitis or other diseases that cause airway stenosis, etc. Other patients with obstructive pulmonary disease assessed by the clinical team Consent signed by the principal or legal representative Age > 20 years old and < 99 years old Exclusion Criteria: Those who cannot place a nasogastric tube due to medical conditions Pregnant women Those who have received gas cutting Patients with phrenic nerve palsy Neuromuscular disease Intubation due to cardiac arrest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Wei Tseng
Phone
+886960-756-606
Ext
28754
Email
kiwitseng724@gmail.com
Facility Information:
Facility Name
Fu Jen Catholic University Hospital All Rights Reserved
City
Taipei
ZIP/Postal Code
24352
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Wei Tseng
Phone
886+905301759
Email
kiwitseng724@gmail.com

12. IPD Sharing Statement

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Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?

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