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

Not Applicable

Not yet recruiting

• Conditions: COPD Exacerbation; Non-invasive Ventilation
• Interventions: Device: Noninvasive Bilevel Positive Pressure Ventilation; Device: Non-invasive high-frequency oscillatory

• Registration Number: NCT05721833
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study Start: 2023-02-10
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bilevel positive pressure ventilation	Noninvasive 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.
non-invasive high-frequency oscillatory ventilation	Non-invasive high-frequency oscillatory	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.

Primary Outcome Measures

Name	Time	Method
Partial pressure of carbon dioxide in peripheral blood	within 50 minutes after intervention	After the peripheral blood was arterialized for 10 minutes, 100 ul of the patient's finger peripheral blood was taken to measure the partial pressure of carbon dioxide in the peripheral blood.

Secondary Outcome Measures

Name	Time	Method
Asynchrony index	within 50 minutes after intervention	Asynchrony index is defined as the number of asynchrony events divided by the total respiratory 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