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

NCT05706467 | Unknown

• 1 other identifier: GYFYY-202301
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19 Pneumonia; Non-invasive Ventilation

Keywords

Noninvasive high frequency oscillatory ventilation; COVID-19 Pneumonia; acute hypoxic respiratory failure

Outcome Measures

Primary Outcomes (1)

• ROX index

  (SpO2/FiO2)/RR

  30 minutes

Secondary Outcomes (1)

• Asynchrony index

  30 minutes

Study Arms (2)

non-invasive high-frequency oscillatory ventilation

EXPERIMENTAL

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

continuous positive airway pressure ventilation

ACTIVE COMPARATOR

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

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

Non-invasive continuous positive airway pressure ventilation DEVICE

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

continuous positive airway pressure ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Officials

• Jianyi Niu, M.D.

  The First Affiliated Hospital of Guangzhou Medical University. Guangdong, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyi Niu, M.D.

CONTACT

+8617825846046; 2020218509@stu.gzhmu.edu.cn

Rongchang Chen, M.D.

CONTACT

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: January 31, 2023
• Study Start: February 10, 2023
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01