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

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05706467

Collaborator

(none)

Enrollment

Arms

3.6

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia Non-invasive Ventilation	Device: Non-invasive high-frequency oscillatory ventilation Device: Non-invasive continuous positive airway pressure ventilation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Subjects who met the inclusion criteria received two kinds of non-invasive positive pressure ventilation treatment, namely, non-invasive continuous positive pressure ventilation and non-invasive high-frequency oscillatory ventilation.Subjects who met the inclusion criteria received two kinds of non-invasive positive pressure ventilation treatment, namely, non-invasive continuous positive pressure ventilation and non-invasive high-frequency oscillatory ventilation.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 10, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: non-invasive high-frequency oscillatory ventilation The day before the test, the patient was titrated with the oxygen concentration under non-invasive ventilation. The non-invasive continuous positive airway pressure ventilation was used, the pressure was set at 8cmH2O, and the oxygen concentration was titrated when the blood oxygen saturation was greater than 92% during non-invasive ventilation, and the oxygen concentration in the respiratory tube was constant after the test. In non-invasive high-frequency oscillatory ventilation mode, maintain the same positive airway pressure setting, and superimpose high-frequency oscillatory airflow with amplitude of 6cmH2O and oscillatory frequency of 10HZ.	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.
Active Comparator: continuous positive airway pressure ventilation The patient was titrated with non-invasive ventilator-related parameters and oxygen uptake concentration the day before the test, and the parameter setting was maintained in the formal experiment.	Device: Non-invasive continuous positive airway pressure ventilation Non-invasive positive airway pressure ventilation is carried out through non-invasive ventilator.

Arm

Intervention/Treatment

Experimental: non-invasive high-frequency oscillatory ventilation

The day before the test, the patient was titrated with the oxygen concentration under non-invasive ventilation. The non-invasive continuous positive airway pressure ventilation was used, the pressure was set at 8cmH2O, and the oxygen concentration was titrated when the blood oxygen saturation was greater than 92% during non-invasive ventilation, and the oxygen concentration in the respiratory tube was constant after the test. In non-invasive high-frequency oscillatory ventilation mode, maintain the same positive airway pressure setting, and superimpose high-frequency oscillatory airflow with amplitude of 6cmH2O and oscillatory frequency of 10HZ.

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.

Active Comparator: continuous positive airway pressure ventilation

The patient was titrated with non-invasive ventilator-related parameters and oxygen uptake concentration the day before the test, and the parameter setting was maintained in the formal experiment.

Device: Non-invasive continuous positive airway pressure ventilation

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

Outcome Measures

Primary Outcome Measures

ROX index [30 minutes]
(SpO2/FiO2)/RR

Secondary Outcome Measures

Asynchrony index [30 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

After COVID-19 nucleic acid detection, imaging confirmed COVID-19;
Age ≥ 18 years old;
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;
Be able to follow the instructions of the researcher.

Exclusion Criteria:

Critically ill patients: cardiac and respiratory arrest, requiring tracheal intubation; Multiple organ failure (>2 organs);
Hemodynamic instability;
After extubation of invasive mechanical ventilation;
Patients who cannot wear a mask, such as maxillofacial or upper airway surgery;
Patients who may affect the treatment effect of NPPV, such as nasal obstruction or upper respiratory tract obstruction;
Obvious bullae, pneumothorax and pleural effusion;
It is accompanied by obvious other respiratory diseases, such as bronchiectasis and lung cancer;
Those who refuse to participate in this test.