The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia

COVID-19 Pneumonia Clinical Trial

Official title:

The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05706467
• Other study ID #: GYFYY-202301
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2023
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Jianyi Niu, M.D.
• Phone: +8617825846046
• Email: 2020218509[@]stu.gzhmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High frequency oscillatory ventilation (HFOV), as an ideal lung protection 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 failure of conventional mechanical ventilation. Although its ability to improve oxygenation and enhance carbon dioxide (CO2) clearance has been repeatedly demonstrated in laboratory studies, its impact on the clinical results of these patients is still uncertain. Noninvasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation, and has become the current research focus in this field. It is recommended to use it after the failure of routine non-invasive ventilation treatment to avoid intubation. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase of clinical application of nHFOV has also enriched its application in the treatment of other diseases. At present, non-invasive high-frequency oscillatory ventilation has not been applied to the study of adult COVID-19 with acute hypoxemia, which will be the first study in this field.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. After COVID-19 nucleic acid detection, imaging confirmed COVID-19;

2. Age = 18 years old;

3. At the time of admission, the blood gas was acute hypoxic respiratory failure, the fraction of inhaled oxygen concentration (Fio2) was at least 0.40, but the blood oxygen saturation (Spo2) was 94% or lower;

4. Be able to follow the instructions of the researcher.

Exclusion Criteria:

1. Critically ill patients: cardiac and respiratory arrest, requiring tracheal intubation; Multiple organ failure (>2 organs);

2. Hemodynamic instability;

3. After extubation of invasive mechanical ventilation;

4. Patients who cannot wear a mask, such as maxillofacial or upper airway surgery;

5. Patients who may affect the treatment effect of NPPV, such as nasal obstruction or upper respiratory tract obstruction;

6. Obvious bullae, pneumothorax and pleural effusion;

7. It is accompanied by obvious other respiratory diseases, such as bronchiectasis and lung cancer;

8. Those who refuse to participate in this test.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Hypoxia
• Non-invasive Ventilation
• Pneumonia

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.
• Non-invasive continuous positive airway pressure ventilation
Non-invasive positive airway pressure ventilation is carried out through non-invasive ventilator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ROX index	(SpO2/FiO2)/RR	30 minutes
Secondary	Asynchrony index	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	30 minutes