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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05595733
Other study ID # FJUH110163
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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