- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706467
The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
January 28, 2023 updated by: Jianyi Niu, Guangzhou Institute of Respiratory Disease
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianyi Niu, M.D.
- Phone Number: +8617825846046
- Email: 2020218509@stu.gzhmu.edu.cn
Study Contact Backup
- Name: Rongchang Chen, M.D.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
Non-invasive positive airway pressure ventilation is carried out through non-invasive ventilator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ROX index
Time Frame: 30 minutes
|
(SpO2/FiO2)/RR
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asynchrony index
Time Frame: 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
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jianyi Niu, M.D., The First Affiliated Hospital of Guangzhou Medical University. Guangdong, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 10, 2023
Primary Completion (ANTICIPATED)
April 30, 2023
Study Completion (ANTICIPATED)
May 30, 2023
Study Registration Dates
First Submitted
January 28, 2023
First Submitted That Met QC Criteria
January 28, 2023
First Posted (ACTUAL)
January 31, 2023
Study Record Updates
Last Update Posted (ACTUAL)
January 31, 2023
Last Update Submitted That Met QC Criteria
January 28, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GYFYY-202301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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