High-flow Nasal CannulaNCT04212182
The Physiological Effect of High Flow Oxygen Therapy
A study testing HFNC and NPPV in people with High-flow Nasal Cannula and Non-invasive Positive Pressure Ventilation, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High-flow Nasal Cannula, Non-invasive Positive Pressure Ventilation, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- HFNC and NPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2019to 1 Jul 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AECOPD patients with acute hypercapnic respiratory failure
Who cannot join
- other lung/pleural diseases or thoracic deformity
- severe heart failure (New York Heart Association class IV), severe dysrhythmia
- unstable angina, or malignant comorbidity
- obesity (BMI ≥ 35 kg/m²)
- severe obstructive sleep apnea syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, 510120
Lili Guan, PhD, +8613422288665, dr_nickguan@163.com
About this study
Official title: The Physiological Effect of High Flow Oxygen Therapy on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.
- Conditions
- High-flow Nasal Cannula, Non-invasive Positive Pressure Ventilation, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Being tested
- HFNC, NPPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.
NPPVDevice
NPPV is the standard therapy for ventilatory failure in AECOPD.
| Study group | Role | What they receive |
|---|---|---|
| HFNC group | Experimental | AECOPD patients receive ventilation support via HFNC. Receives: Device: HFNC |
| NPPV group | Active comparator | AECOPD patients receive ventilation support via NPPV. Receives: Device: NPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural respiratory drive
Neural respiratory drive is calculated by diaphragm electromyogram
Measured: 30 minutes
Secondary outcomes (2)
Work of breathing
Work of breathing is calculated by the transdiaphragmatic pressure
Measured: 30 minutes
Transcutaneous CO2
Transcutaneous CO2 is a non-invasive method estimated the partial pressure of arterial blood CO2.
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 posted26 Dec 2019
- Study start27 Dec 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-flow Nasal CannulaStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongchang Chen, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, MD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212182
- Sponsor's protocol ID
- GIRH-HFNC8306
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guan L, Xu J, He Z, Zha S, Huang Q, Niu J, Zhou L, Chen R. Efficiency of neural respiratory drive changes during non-invasive ventilation and high-flow nasal cannula oxygen therapy in AECOPD patients with acute hypercapnic respiratory failure: A randomised cross-over study. Ann Intensive Care. 2026 Jan 16;16:100019. doi: 10.1016/j.aicoj.2025.100019. eCollection 2026.
PubMed 41788481
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Effect of High Flow Oxygen Therapy on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04212182
- Acronym / sponsor ID
- GIRH-HFNC8306
- Conditions
- High-flow Nasal Cannula, Non-invasive Positive Pressure Ventilation, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 26 Dec 2019 (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.
Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC group | Experimental | Device: HFNCAECOPD patients receive ventilation support via HFNC. |
| NPPV group | Active comparator | Device: NPPVAECOPD patients receive ventilation support via NPPV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AECOPD patients with acute hypercapnic respiratory failure
Key exclusion criteria (5 listed)
- other lung/pleural diseases or thoracic deformity
- severe heart failure (New York Heart Association class IV), severe dysrhythmia
- unstable angina, or malignant comorbidity
- obesity (BMI ≥ 35 kg/m²)
- severe obstructive sleep apnea syndrome
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 |
|---|---|---|
| HFNCHFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs. | Device | HFNC group |
| NPPVNPPV is the standard therapy for ventilatory failure in AECOPD. | Device | NPPV group |
Primary outcome
Neural respiratory drive
Time frame: 30 minutes
Neural respiratory drive is calculated by diaphragm electromyogram
2 secondary outcomes
Work of breathing
Time frame: 30 minutes
Transcutaneous CO2
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 30 Dec 2019.
- Derived from this study: PubMed 41788481Guan L, Xu J, He Z, Zha S, Huang Q, Niu J, Zhou L, Chen R. Efficiency of neural respiratory drive changes during non-invasive ventilation and high-flow nasal cannula oxygen therapy in AECOPD patients with acute hypercapnic respiratory failure: A randomised cross-over study. Ann Intensive Care. 2026 Jan 16;16:100019. doi: 10.1016/j.aicoj.2025.100019. eCollection 2026.
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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, MD study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and NPPV in people with High-flow Nasal Cannula and Non-invasive Positive Pressure Ventilation, run by The First Affiliated Hospital of Guangzhou Medical University 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 1 inclusion and 5 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 30 Dec 2019. 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 Lili Guan, PhD (+8613422288665, dr_nickguan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural respiratory drive (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212182, which also lists 1 linked publication.
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 30 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.