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

NCT05448417 | Unknown

• 1 other identifier: GZ-202203
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-invasive Ventilation; Healthy Subjects

Keywords

Noninvasive high frequency oscillatory ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

non-invasive high-frequency oscillatory ventilation

EXPERIMENTAL

Patients were titrated for relevant parameters of noninvasive ventilation the day before the trial. In the non-invasive high-frequency oscillation ventilation mode, the support pressure is consistent with the noninvasive bi-level positive pressure mode, and the highfrequency airway pressure oscillation driven by the solenoid valve is added during the expiratory phase. The amplitude is about 4cmH2O, and the oscillation frequency is about 8HZ.

Device: Non-invasive high-frequency oscillatory ventilation

Bilevel positive pressure ventilation

ACTIVE COMPARATOR

Bilevel positive pressure ventilation Patients were titrated for relevant parameters of non-invasive ventilation the day before the trial. Noninvasive bilevel positive pressure ventilation mode pressure titration follows previous studies.

Device: Noninvasive Bilevel Positive Pressure Ventilation

Interventions

Non-invasive high-frequency oscillatory ventilation DEVICE

Non-invasive high-frequency oscillatory ventilation generates high-frequency pressure fluctuations in the airway caused by the opening and closing of a solenoid valve.

non-invasive high-frequency oscillatory ventilation

Noninvasive Bilevel Positive Pressure Ventilation DEVICE

Noninvasive Bilevel Positive Pressure Ventilation

Bilevel positive pressure ventilation

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-40, males and females;
• Pulmonary function test found that the subject's lung function was normal;
• Pulmonary disease not related to the results of the experiment;
• Willing to participate in the study;
• Able to provide informed consent.

You may not qualify if:

• Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
• Intolerant with NIV

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University.

Guangdong, China

Location

Central Study Contacts

Jianyi Niu, MD

CONTACT

+8617825846046; niujianyi001@163.com

Rongchang Chen, MD

CONTACT

178258460

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 7, 2022
• Study Start: July 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: July 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

CN (1)