- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05595733
Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?
Can Neurally Adjusted Ventilatory Assist Mode Reduce Mechanical Ventilation Day in Patients With Chronic Obstructive Pulmonary Disease ?
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 24352
- Fu Jen Catholic University Hospital All Rights Reserved
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: conventional group
Using conventional mode to compare mechanical ventilation day with experimental group
|
|
|
Experimental: experimental group
Using neurally adjusted ventilatory assist mode to compare mechanical ventilation day with conventional group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ventilator-free days(VFDs)
Time Frame: up to 28 days
|
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. |
up to 28 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJUH110163
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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