Respiratory InsufficiencyNCT05435079
Research on a NTHF to Improve Pulmonary Function in Patients With Respiratory Failure
A study testing high-flow oxygen therapy device for tracheotomized patients in people with Respiratory Insufficiency, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, in-depth research on early weaning and oxygen therapy nursing mode is needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- high-flow oxygen therapy device for tracheotomized patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2024
- 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
- Patient who ≥18 years old and meets the diagnostic criteria for respiratory failure
- Have an artificial airway, ready or have been released from the ventilator
- The circulation is basically stable, and there are no shocks of various types that are difficult to correct (mean arterial pressure remains unchanged under the condition of vasoactive drugs).
- <65mmHg)
- Consciousness and ability to cooperate with clinical treatment
Who cannot join
- Pregnancy and end-stage cancer patients
- History of airway injury, pulmonary trauma, and lung surgery
- Central respiratory failure or status asthmaticus caused by neurological diseases
- Refusing to cooperate with treatment or to participate in the researcher
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000
MEI YANG, 13509682339, yangmei3056@163.com
About this study
Official title: Research on a New Nursing Model of New High-flow Oxygen Inhalation Device to Improve Pulmonary Function in Patients With Respiratory Failure
Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, in-depth research on early weaning and oxygen therapy nursing mode is needed. Currently, studies on artificial airway high-flow oxygen therapy are limited. Studies have reported that oxygen inhalation devices that increase expiratory resistance produce flow-dependent positive airway pressure and lung volume effects that improve oxygenation and ventilation. It means that the innovation of oxygen therapy device may be a change The key to improving lung function and reducing mechanical ventilation in patients with respiratory failure.
The project team is committed to the innovation of high-flow oxygen therapy devices and the research on oxygen therapy care. In the early stage, the "New Artificial Airway High Flow Oxygen Therapy Device" was designed (NTHF), in 2018, the new technology and new projects were declared and approved to solve the problem of the flow rate of oxygen therapy devices. In the pre-test, 78 tracheotomy patients were observed using NTHF and respiratory humidification therapy device (AIRVOTM2 ) with high-flow oxygen therapy. As a result, NTHF was superior to AIRVOTM2 in improving airway humidification, oxygenation effect and cost, and published an article, which was approved in 2019 "Non-inferiority of humidification performance of a novel high-flow oxygen therapy device in oxygen therapy for tracheostomy-off-weaned patients. In 2021, it will be approved for the promotion of appropriate technologies for health and health in Guangdong Province. Relying on the high-level clinical key specialties of Guangdong Province, support with scientific research technology and financial support conditions.
Research hypothesis: NTHF has the physiological effects of increasing the positive expiratory pressure of artificial airway, alveolar ventilation, and humidification, and can improve the lung function of patients with respiratory failure after tracheotomy.
Read the detailed description
1.1 Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, it is necessary to In-depth study of daily off-line and oxygen therapy nursing mode. Currently, studies on artificial airway high-flow oxygen therapy are limited. Studies have reported that increased expiratory resistance Oxygen inhalation devices produce flow-dependent positive airway pressure and lung volume effects that improve oxygenation and ventilation. It means that the innovation of oxygen therapy device may be a change.The key to improving lung function and reducing mechanical ventilation in patients with respiratory failure.
1.2 The project team is committed to the innovation of high-flow oxygen therapy devices and research on oxygen therapy care. In the early stage, the "New Artificial Airway High Flow Oxygen Therapy Device" was designed (NTHF), in 2018, the new technology and new projects were declared and approved to solve the flow rate problem of oxygen therapy devices ,observing 78 tracheotomized patients using NTHF and respiratory humidification therapy device (AIRVOTM2) Perform high-flow oxygen therapy. As a result, NTHF was superior to AIRVOTM2 in improving airway humidification, oxygenation, and cost, and published an article. Approved in 2019 "New high-flow oxygen therapy device in tracheotomy Non-inferiority study of humidification performance in oxygen therapy for weaned patients" (funded 150,000 yuan, China Clinical Research Registry, ChiCTR1900023421). 2021 , it was approved to promote the "Artificial Airway High Flow Oxygen Therapy Airtight Suction Technology" in Guangdong Province for Health and Health Appropriate Technology . Relying on Guangdong Province High-level clinical key specialties,support with scientific research technology and financial support condition.
1.3 Scientific assumption: NTHF has the physiological effects of increasing positive expiratory pressure of artificial airway, alveolar ventilation, and humidification, and can improve respiratory failure trachea,The patient's lung function was incised.
2 goals 2.1 To evaluate the effect of NTHF on improving pulmonary ventilation, ventilation and defense function in patients with respiratory failure artificial airway.
2.2 Obtain evidence that NTHF improves pulmonary function in patients with respiratory failure, and establish a new model of oxygen therapy nursing for patients with artificial airway in respiratory failure.
3 Research content 3.1 In a randomized parallel control method, NTHF and AIRVOTM2 were used in two groups of patients with respiratory failure artificial airway, and the two groups of patients were observed for 7 days.
The oxygenation index, respiratory rate, and mechanical ventilation time were analyzed, and the improvement of oxygenation in patients with respiratory failure by two oxygen therapy devices was analyzed.
3.2 Comparing the results of pulmonary function tests and microbial metagenomic testing of the two groups of patients before treatment and after 7 days of treatment, to explore the effect of NTHF on improving pulmonary function and patient comfort in patients with mild and moderate respiratory failure, and to explore the effect of NTHF in patients with respiratory failure caused by different diseases. A new model of oxygen therapy care.
4 Key issues to be addressed 4.1 To verify the effect of the new high-flow oxygen therapy device in improving oxygenation, ventilation and humidification of patients with respiratory failure artificial airway.
4.2 To explore whether the new high-flow oxygen therapy device can improve the lung function of patients with respiratory failure artificial airway, and establish a new model of oxygen therapy nursing.
5 Expected results 5.1 Academic indicators: Establish a personalized weaning scheme for patients with respiratory failure and a new nursing model for tracheotomy and high-flow humidified oxygen therapy. Published papers 1-2Participate in academic exchange conferences.
5.2 Talent training: train 1-2 respiratory therapists and graduate students. 5.3 Social and economic benefits: reduce the time of mechanical ventilation in patients with respiratory failure,Shorten the days of hospitalization, reduce costs, and reduce the burden on families and society.
- Conditions
- Respiratory Insufficiency
- Being tested
- high-flow oxygen therapy device for tracheotomized patients
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow oxygen therapy device for tracheotomized patientsDevice
From the output end of the automatic pressure-adjustable oxygen flow meter, connect the oxygen suction tube, Venturi, Fisher \& Paykel MR850 heated humidifier, RT308 breathing tube with humidification tank, closed sputum suction tube and tracheostomy tube), Adjust the MR850 to invasive automatic transmission, the temperature sensor automatically adjusts and maintains the gas temperature at the inlet of the tracheostomy tube at 37°C according to the feedback temperature, and adjusts the oxygen therapy device according to the gas outflow from the exhalation port of the patient's inspiratory phase. The gas flow rate is 40-60L/min. According to the monitored pulse oxygen saturation (SpO 2 ), the concentration of the venturi valve and the corresponding oxygen flow rate are adjusted to maintain the SpO 2 between 94% and 100%.
| Study group | Role | What they receive |
|---|---|---|
| new type of tracheotomy high-flow oxygen therapy (NTHF) | Experimental | NTHF (connect the oxygen suction tube, Venturi, Fisher \& Paykel MR850 heated humidifier, RT308 breathing tube with humidification tank, airtight suction tube and tracheotomy in sequence from the output end of the automatic pressure-adjustable oxygen flow meter Catheter), adjust the MR850 to invasive automatic transmission, the temperature sensor automatically adjusts and maintains the gas temperature at the inlet of the tracheostomy catheter at 37°C according to the feedback temperature, and adjusts according to the gas outflow from the exhalation port of the patient's inspiratory phase. The gas flow rate of the oxygen therapy device is 40-60L/min. According to the monitored pulse oxygen saturation (SpO 2 ), the concentration of the venturi valve and the corresponding oxygen flow rate are adjusted to maintain the SpO 2 between 94% and 100%. Receives: Device: high-flow oxygen therapy device for tracheotomized patients |
| Respiratory Humidification Treatment（ AIRVO TM 2） | Active comparator | AIRVOTM 2 (Fisher \& Paykel, Auckland, New Zealand), connect the special breathing circuit, tracheostomy joint and tracheostomy tube in sequence from the output end of the oxygen flow meter. The gas outflow from the mouth is the standard, adjust the output gas flow rate of the therapy device to 40-60L/min, adjust the oxygen concentration according to the monitored pulse oxygen saturation (SpO 2 ), and maintain the SpO 2 between 94% and 100%. . Receives: Device: high-flow oxygen therapy device for tracheotomized patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of oxygenation
Oxygenation is assessed by arterial blood gas sample
Measured: 24hours after start of high flow oxygen therapy
Level of oxygenation
Oxygenation is assessed by arterial blood gas sample
Measured: 48 hours after start of high flow oxygen therapy
Level of oxygenation
Oxygenation is assessed by arterial blood gas sample
Measured: 7th days after start of high flow oxygen therapy
Secondary outcomes (2)
level of sputum viscosity
sputum viscosity is assessed with a sputum viscometer
Measured: 24th, 48th and 7th days after start of high flow oxygen therapy
Patient satisfaction scoreg greater than or equal to 90
Using Hospital Designated Satisfaction Questionnaire which include comfort, bloating, dry mouth, ability to hear and speak（Total score is 100 points）
Measured: the 7th day after start of high flow oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before the start of the study, all enrolled patients were required to sign an informed consent form. Patients who met the inclusion criteria were divided into NTHF (observation group) and AIRVOTM2 (Fisher \& Paykel, Auckland, New Zealand) group (control group) in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MEI YANGMEI, Study chair, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435079
- Sponsor's protocol ID
- A2022088
- Status last verified
- Apr 2022
- First submitted
- 14 May 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on a New Nursing Model of New High-flow Oxygen Inhalation Device to Improve Pulmonary Function in Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT05435079
- Acronym / sponsor ID
- A2022088
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Jun 2022 (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.
Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, in-depth research on early weaning and oxygen therapy nursing mode is needed. Currently, studies on artificial airway high-flow oxygen therapy are limited. Studies have reported that oxygen inhalation devices that increase expiratory resistance produce flow-dependent positive airway pressure and lung volume effects that improve oxygenation and ventilation. It means that the innovation of oxygen therapy device may be a change The key to improving lung function and reducing mechanical ventilation in patients with respiratory failure.
The project team is committed to the innovation of high-flow oxygen therapy devices and the research on oxygen therapy care. In the early stage, the "New Artificial Airway High Flow Oxygen Therapy Device" was designed (NTHF), in 2018, the new technology and new projects were declared and approved to solve the problem of the flow rate of oxygen therapy devices. In the pre-test, 78 tracheotomy patients were observed using NTHF and respiratory humidification therapy device (AIRVOTM2 ) with high-flow oxygen therapy. As a result, NTHF was superior to AIRVOTM2 in improving airway humidification, oxygenation effect and cost, and published an article, which was approved in 2019 "Non-inferiority of humidification performance of a novel high-flow oxygen therapy device in oxygen therapy for tracheostomy-off-weaned patients. In 2021, it will be approved for the promotion of appropriate technologies for health and health in Guangdong Province. Relying on the high-level clinical key specialties of Guangdong Province, support with scientific research technology and financial support conditions.
Research hypothesis: NTHF has the physiological effects of increasing the positive expiratory pressure of artificial airway, alveolar ventilation, and humidification, and can improve the lung function of patients with respiratory failure after tracheotomy.
Detailed description
1.1 Patients with respiratory failure have high morbidity and mortality. Long-term mechanical ventilation causes a high medical burden and cannot cure respiratory failure. Therefore, it is necessary to In-depth study of daily off-line and oxygen therapy nursing mode. Currently, studies on artificial airway high-flow oxygen therapy are limited. Studies have reported that increased expiratory resistance Oxygen inhalation devices produce flow-dependent positive airway pressure and lung volume effects that improve oxygenation and ventilation. It means that the innovation of oxygen therapy device may be a change.The key to improving lung function and reducing mechanical ventilation in patients with respiratory failure.
1.2 The project team is committed to the innovation of high-flow oxygen therapy devices and research on oxygen therapy care. In the early stage, the "New Artificial Airway High Flow Oxygen Therapy Device" was designed (NTHF), in 2018, the new technology and new projects were declared and approved to solve the flow rate problem of oxygen therapy devices ,observing 78 tracheotomized patients using NTHF and respiratory humidification therapy device (AIRVOTM2) Perform high-flow oxygen therapy. As a result, NTHF was superior to AIRVOTM2 in improving airway humidification, oxygenation, and cost, and published an article. Approved in 2019 "New high-flow oxygen therapy device in tracheotomy Non-inferiority study of humidification performance in oxygen therapy for weaned patients" (funded 150,000 yuan, China Clinical Research Registry, ChiCTR1900023421). 2021 , it was approved to promote the "Artificial Airway High Flow Oxygen Therapy Airtight Suction Technology" in Guangdong Province for Health and Health Appropriate Technology . Relying on Guangdong Province High-level clinical key specialties,support with scientific research technology and financial support condition.
1.3 Scientific assumption: NTHF has the physiological effects of increasing positive expiratory pressure of artificial airway, alveolar ventilation, and humidification, and can improve respiratory failure trachea,The patient's lung function was incised.
2 goals 2.1 To evaluate the effect of NTHF on improving pulmonary ventilation, ventilation and defense function in patients with respiratory failure artificial airway.
2.2 Obtain evidence that NTHF improves pulmonary function in patients with respiratory failure, and establish a new model of oxygen therapy nursing for patients with artificial airway in respiratory failure.
3 Research content 3.1 In a randomized parallel control method, NTHF and AIRVOTM2 were used in two groups of patients with respiratory failure artificial airway, and the two groups of patients were observed for 7 days.
The oxygenation index, respiratory rate, and mechanical ventilation time were analyzed, and the improvement of oxygenation in patients with respiratory failure by two oxygen therapy devices was analyzed.
3.2 Comparing the results of pulmonary function tests and microbial metagenomic testing of the two groups of patients before treatment and after 7 days of treatment, to explore the effect of NTHF on improving pulmonary function and patient comfort in patients with mild and moderate respiratory failure, and to explore the effect of NTHF in patients with respiratory failure caused by different diseases. A new model of oxygen therapy care.
4 Key issues to be addressed 4.1 To verify the effect of the new high-flow oxygen therapy device in improving oxygenation, ventilation and humidification of patients with respiratory failure artificial airway.
4.2 To explore whether the new high-flow oxygen therapy device can improve the lung function of patients with respiratory failure artificial airway, and establish a new model of oxygen therapy nursing.
5 Expected results 5.1 Academic indicators: Establish a personalized weaning scheme for patients with respiratory failure and a new nursing model for tracheotomy and high-flow humidified oxygen therapy. Published papers 1-2Participate in academic exchange conferences.
5.2 Talent training: train 1-2 respiratory therapists and graduate students. 5.3 Social and economic benefits: reduce the time of mechanical ventilation in patients with respiratory failure,Shorten the days of hospitalization, reduce costs, and reduce the burden on families and society.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before the start of the study, all enrolled patients were required to sign an informed consent form. Patients who met the inclusion criteria were divided into NTHF (observation group) and AIRVOTM2 (Fisher \& Paykel, Auckland, New Zealand) group (control group) in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| new type of tracheotomy high-flow oxygen therapy (NTHF) | Experimental | Device: high-flow oxygen therapy device for tracheotomized patientsNTHF (connect the oxygen suction tube, Venturi, Fisher \& Paykel MR850 heated humidifier, RT308 breathing tube with humidification tank, airtight suction tube and tracheotomy in sequence from the output end of the automatic pressure-adjustable oxygen flow meter Catheter), adjust the MR850 to invasive automatic transmission, the temperature sensor automatically adjusts and maintains the gas temperature at the inlet of the tracheostomy catheter at 37°C according to the feedback temperature, and adjusts according to the gas outflow from the exhalation port of the patient's inspiratory phase. The gas flow rate of the oxygen therapy device is 40-60L/min. According to the monitored pulse oxygen saturation (SpO 2 ), the concentration of the venturi valve and the corresponding oxygen flow rate are adjusted to maintain the SpO 2 between 94% and 100%. |
| Respiratory Humidification Treatment（ AIRVO TM 2） | Active comparator | Device: high-flow oxygen therapy device for tracheotomized patientsAIRVOTM 2 (Fisher \& Paykel, Auckland, New Zealand), connect the special breathing circuit, tracheostomy joint and tracheostomy tube in sequence from the output end of the oxygen flow meter. The gas outflow from the mouth is the standard, adjust the output gas flow rate of the therapy device to 40-60L/min, adjust the oxygen concentration according to the monitored pulse oxygen saturation (SpO 2 ), and maintain the SpO 2 between 94% and 100%. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who ≥18 years old and meets the diagnostic criteria for respiratory failure
- Have an artificial airway, ready or have been released from the ventilator
- The circulation is basically stable, and there are no shocks of various types that are difficult to correct (mean arterial pressure remains unchanged under the condition of vasoactive drugs).
- <65mmHg)
- Consciousness and ability to cooperate with clinical treatment
Key exclusion criteria (4 listed)
- Pregnancy and end-stage cancer patients
- History of airway injury, pulmonary trauma, and lung surgery
- Central respiratory failure or status asthmaticus caused by neurological diseases
- Refusing to cooperate with treatment or to participate in the researcher
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 |
|---|---|---|
| high-flow oxygen therapy device for tracheotomized patientsFrom the output end of the automatic pressure-adjustable oxygen flow meter, connect the oxygen suction tube, Venturi, Fisher \& Paykel MR850 heated humidifier, RT308 breathing tube with humidification tank, closed sputum suction tube and tracheostomy tube), Adjust the MR850 to invasive automatic transmission, the temperature sensor automatically adjusts and maintains the gas temperature at the inlet of the tracheostomy tube at 37°C according to the feedback temperature, and adjusts the oxygen therapy device according to the gas outflow from the exhalation port of the patient's inspiratory phase. The gas flow rate is 40-60L/min. According to the monitored pulse oxygen saturation (SpO 2 ), the concentration of the venturi valve and the corresponding oxygen flow rate are adjusted to maintain the SpO 2 between 94% and 100%. | Device | Respiratory Humidification Treatment（ AIRVO TM 2）, new type of tracheotomy high-flow oxygen therapy (NTHF) |
Primary outcome
Level of oxygenation
Time frame: 24hours after start of high flow oxygen therapy
Oxygenation is assessed by arterial blood gas sample
Level of oxygenation
Time frame: 48 hours after start of high flow oxygen therapy
Oxygenation is assessed by arterial blood gas sample
Level of oxygenation
Time frame: 7th days after start of high flow oxygen therapy
Oxygenation is assessed by arterial blood gas sample
2 secondary outcomes
level of sputum viscosity
Time frame: 24th, 48th and 7th days after start of high flow oxygen therapy
Patient satisfaction scoreg greater than or equal to 90
Time frame: the 7th day after start of high flow oxygen therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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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.
MEI YANGMEI study chair
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-flow oxygen therapy device for tracheotomized patients in people with Respiratory Insufficiency, run by Shenzhen Second People's Hospital at 1 site in China.
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 5 inclusion and 4 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 WENJING QIAN (0755-83464301, hyyoung95@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of oxygenation (time frame: 24hours after start of high flow oxygen therapy). The study lists 3 primary outcomes in all. 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 28 Jun 2022.