Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448417
Enrollment
10
Registered
2022-07-07
Start date
2022-07-15
Completion date
2023-07-01
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-invasive Ventilation, Healthy Subjects

Keywords

Noninvasive high frequency oscillatory ventilation

Brief 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.

Interventions

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

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients were randomized to receive one hour each of the two non-invasive ventilation modes before and after, and one hour of washout after receiving the first mode of ventilation before receiving the second intervention.

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Asynchrony index1 hourAsynchrony 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

Countries

China

Contacts

Primary ContactJianyi Niu, MD
niujianyi001@163.com+8617825846046
Backup ContactRongchang Chen, MD
178258460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026