Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects : a Clinical Crossover Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05448417
• Other study ID #: GZ-202203
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2022
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Jianyi Niu, MD
• Phone: +8617825846046
• Email: niujianyi001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually applied to neonatal intensive care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after conventional mechanical treatment fails. ventilation. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a research hotspot in this field. Recommended to avoid intubation after failure of conventional non-invasive ventilation therapy. There is a lack of large-scale clinical trials systematically exploring its efficacy for intubation therapy. The increasing clinical application of nHFOV has also enriched its application in the treatment of other diseases. Human-machine asynchrony during non-invasive ventilation will seriously affect its efficacy, but no one has reported on the research related to nHFOV human-machine asynchrony.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Age 25-40, males and females;

2. Pulmonary function test found that the subject's lung function was normal;

3. Pulmonary disease not related to the results of the experiment;

4. Willing to participate in the study;

5. Able to provide informed consent.

Exclusion Criteria:

1. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.

2. Intolerant with NIV

Related Conditions & MeSH terms

• Healthy Subjects
• Non-invasive Ventilation

Intervention

Device:
• Non-invasive high-frequency oscillatory ventilation
Non-invasive high-frequency oscillatory ventilation generates high-frequency pressure fluctuations in the airway caused by the opening and closing of a solenoid valve.
• Noninvasive Bilevel Positive Pressure Ventilation
Noninvasive Bilevel Positive Pressure Ventilation

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University.	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony index	Asynchrony index is defined as the number of asynchrony events divided by the total espiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts: asynchrony Index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100	1 hour