COVID-19 PneumoniaNCT05706467
The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
A study testing Non-invasive high-frequency oscillatory ventilation and Non-invasive continuous positive airway pressure ventilation in people with COVID-19 Pneumonia and Non-invasive Ventilation, run by Guangzhou Institute of Respiratory Disease.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Non-invasive Ventilation
- What is being tested?
- Non-invasive high-frequency oscillatory ventilation and Non-invasive continuous positive airway pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Rongchang Chen, M.D. contact
About this study
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
- Being tested
- Non-invasive high-frequency oscillatory ventilation, Non-invasive continuous positive airway pressure ventilation
- Keywords
- Noninvasive high frequency oscillatory ventilation, COVID-19 Pneumonia, acute hypoxic respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive high-frequency oscillatory ventilationDevice
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 ventilationDevice
Non-invasive positive airway pressure ventilation is carried out through non-invasive ventilator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Non-invasive continuous positive airway pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROX index
(SpO2/FiO2)/RR
Measured: 30 minutes
Secondary outcomes (1)
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start10 Feb 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Niu, Guangzhou Institute of Respiratory Disease
- Investigators
- Jianyi Niu, M.D., Principal investigator, The First Affiliated Hospital of Guangzhou Medical University. Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706467
- Sponsor's protocol ID
- GYFYY-202301
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
- ClinicalTrials.gov ID
- NCT05706467
- Acronym / sponsor ID
- GYFYY-202301
- Conditions
- COVID-19 Pneumonia, Non-invasive Ventilation
- Keywords
- Noninvasive high frequency oscillatory ventilation, COVID-19 Pneumonia, acute hypoxic respiratory failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 10 Feb 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| non-invasive high-frequency oscillatory ventilation | Experimental | Device: Non-invasive high-frequency oscillatory ventilationThe 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. |
| continuous positive airway pressure ventilation | Active comparator | Device: Non-invasive continuous positive airway pressure ventilationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive high-frequency oscillatory ventilationNon-invasive high-frequency oscillatory ventilation generates high-frequency pressure fluctuations in the airway caused by the opening and closing of a solenoid valve. | Device | non-invasive high-frequency oscillatory ventilation |
| Non-invasive continuous positive airway pressure ventilationNon-invasive positive airway pressure ventilation is carried out through non-invasive ventilator. | Device | continuous positive airway pressure ventilation |
Primary outcome
ROX index
Time frame: 30 minutes
(SpO2/FiO2)/RR
1 secondary outcome
Asynchrony index
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongchang Chen, M.D. contact
Jianyi Niu, M.D. principal investigator
The First Affiliated Hospital of Guangzhou Medical University. Guangdong, China
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive high-frequency oscillatory ventilation and Non-invasive continuous positive airway pressure ventilation in people with COVID-19 Pneumonia and Non-invasive Ventilation, run by Guangzhou Institute of Respiratory Disease.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianyi Niu, M.D. (+8617825846046, 2020218509@stu.gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROX index (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.