NCT05595733

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

October 11, 2022

Last Update Submit

February 12, 2026

Conditions

Keywords

Neurally Adjusted Ventilatory Assistventilator-free dayspatient-ventilator synchronydiaphragm atrophyChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Device: Ventilator mode

Interventions

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.

experimental group

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital All Rights Reserved

Taipei, 24352, Taiwan

Location

MeSH Terms

Conditions

Lung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 27, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations