Obstructive Lung DiseasesNCT05595733
Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?
A study testing Ventilator mode in people with Obstructive Lung Diseases, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Obstructive Lung Diseases
- What is being tested?
- Ventilator mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital All Rights Reserved
Taipei, 24352
About this study
Official title: 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
- Conditions
- Obstructive Lung Diseases
- Being tested
- Ventilator mode
- Keywords
- Neurally Adjusted Ventilatory Assist, ventilator-free days, patient-ventilator synchrony, diaphragm atrophy, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator modeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | No intervention | Using conventional mode to compare mechanical ventilation day with experimental group |
| experimental group | Experimental | Using neurally adjusted ventilatory assist mode to compare mechanical ventilation day with conventional group Receives: Device: Ventilator mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595733
- Sponsor's protocol ID
- FJUH110163
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Neurally Adjusted Ventilatory Assist Mode Reduce Mechanical Ventilation Day in Patients With Chronic Obstructive Pulmonary Disease ?
- ClinicalTrials.gov ID
- NCT05595733
- Acronym / sponsor ID
- FJUH110163
- Conditions
- Obstructive Lung Diseases
- Keywords
- Neurally Adjusted Ventilatory Assist, ventilator-free days, patient-ventilator synchrony, diaphragm atrophy, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | No intervention | –Using conventional mode to compare mechanical ventilation day with experimental group |
| experimental group | Experimental | Device: Ventilator modeUsing neurally adjusted ventilatory assist mode to compare mechanical ventilation day with conventional group |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator modeNeurally 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. | Device | experimental group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator mode in people with Obstructive Lung Diseases, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator-free days(VFDs) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.