Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving CO2 Clearance in COPD Patients

NCT ID: NCT05721833

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2023-06-30

Brief Summary

High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually used in neonatal critical care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after failure of conventional mechanical ventilation. . Although its ability to improve oxygenation and enhance carbon dioxide (CO2) scavenging has been repeatedly demonstrated in laboratory studies, its impact on clinical outcomes in these patients remains uncertain. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a current research hotspot in this field. It is recommended to be used to avoid intubation after conventional non-invasive ventilation therapy fails. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase in the clinical application of nHFOV has also enriched its use in the treatment of other diseases

Conditions

COPD Exacerbation; Non-invasive Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non-invasive high-frequency oscillatory ventilation

Patients were titrated for relevant parameters of non-invasive ventilation the day before the trial. In the non-invasive high-frequency oscillation ventilation mode, the support pressure is consistent with the non-invasive bi-level positive pressure mode, and the high frequency 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.

Group Type: EXPERIMENTAL

Non-invasive high-frequency oscillatory

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Noninvasive Bilevel Positive Pressure Ventilation

Intervention Type: DEVICE

Noninvasive Bilevel Positive Pressure Ventilation.

Interventions

Non-invasive high-frequency oscillatory

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

Intervention Type: DEVICE

Noninvasive Bilevel Positive Pressure Ventilation

Noninvasive Bilevel Positive Pressure Ventilation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 40-80, males and females;

2. Stage III and IV COPD and PaCO2≥50mmHg;

3. Similar with non-invasive ventilation;

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Jianyi Niu

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jianyi Niu, MD

Role: CONTACT

niujianyi001@163.com

+8617825846046

Rongchang Chen, PhD

Role: CONTACT

Other Identifiers

GIRH-202203-1

Identifier Type: -

Identifier Source: org_study_id