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

Obstructive Lung Diseases Clinical Trial

Official title:

Can Neurally Adjusted Ventilatory Assist Mode Reduce Mechanical Ventilation Day in Patients With Chronic Obstructive Pulmonary Disease ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595733
• Other study ID #: FJUH110163
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Fu Jen Catholic University Hospital
• Contact: Chi-Wei Tseng
• Phone: +886960-756-606
• Email: kiwitseng724[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Diseases

Intervention

Device:
• Ventilator mode
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.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital All Rights Reserved	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 28 days