Chronic Obstructive Pulmonary Disease (COPD)NCT06992479

Efficacy of HFNC Combined With Sequential NIV in Patients With COPD Complicated With Type II Respiratory Failure

A study testing high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV) and NIV routine treatment in people with Chronic Obstructive Pulmonary Disease (COPD) and Nasal High Flow Oxygen Therapy, run by Beijing YouAn Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to investigate the efficacy of high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV) in patients with chronic obstructive pulmonary disease complicated with type II respiratory failure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD), Nasal High Flow Oxygen Therapy, Noninvasive Ventilation
What is being tested?: high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV) and NIV routine treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: 1 Jan 2021to 31 Jan 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

All subjects included in the study met the diagnostic criteria for AECOPD in the Global Initiative for Chronic Obstructive Pulmonary Disease (2014 Update);
Age > 18 years old;
All patients met the diagnostic criteria for type II respiratory failure in the eighth edition of ' Internal Medicine ', that was, arterial blood PaO2 < 50mmHg;
The patient was conscious, without myocardial infarction, acute stroke, severe liver and kidney dysfunction, severe coagulation dysfunction and other diseases;
The patient did not have life-threatening hypoxemia and severe hemodynamic instability, and did not need tracheal intubation or tracheotomy;
Patients can cooperate with pulmonary function tests.

Who cannot join

Patients with pneumothorax, mediastinal emphysema or severe thoracic deformity;
Patients with bronchial asthma, interstitial pneumonia and other diseases;
Patients with coma and disturbance of consciousness;
The upper respiratory tract or facial injury and facial deformity, can not wear a good nose (face) mask;
Patients with septic shock or severe heart, kidney, liver and other diseases;
Sputum and sticky, unable to expectoration or prone to aspiration caused by airway obstruction.
Automatic discharge or transfer, or due to non-respiratory serious diseases (including non-invasive ventilator complications, non-invasive ventilation treatment ineffective need to be changed to invasive ventilation), termination of the study patients.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing You'an Hospital, Capital Medical University
Beijing

Other trials in China

About this study

Official title: Efficacy of Nasal High-flow Oxygen Therapy Combined With Sequential Non-invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Complicated With Type II Respiratory Failure

What is the effect of high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation on arterial blood gas indicators in patients with chronic obstructive pulmonary disease and type II respiratory failure? What is the effect of high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation on pulmonary ventilation function in patients with chronic obstructive pulmonary disease and type II respiratory failure? What is the effect of high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation on vital signs in patients with chronic obstructive pulmonary disease and type II respiratory failure? What is the effect of high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation on the quality of life of patients with chronic obstructive pulmonary disease and type II respiratory failure? What is the effect of high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation on complications in patients with chronic obstructive pulmonary disease and type II respiratory failure?

Participants will:

Receive NIV through a full mask or nasal mask using any of the existing ventilators in the hospital Receive other standard treatments according to the latest GOLD guidelines The general data of patients, arterial blood gas index, pulmonary ventilation function, vital signs index, quality of life and complications before and after treatment were collected.

Conditions: Chronic Obstructive Pulmonary Disease (COPD), Nasal High Flow Oxygen Therapy, Noninvasive Ventilation, Respiratory Failure
Being tested: high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV), NIV routine treatment
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV)Device
The control group was treated with NIV routine treatment. During non-invasive ventilation, patients in both the intervention group and the conventional group will receive NIV through a full mask or nasal mask using any of the existing ventilators in the hospital. Usually, the ventilator was set to the pressure support ventilation mode, and the inspiratory pressure was adjusted to the maximum tolerance to obtain the ideal body weight of 6 ~ 8mL / kg of exhaled tidal volume, and the PEEP was set at 3 ~ 5cmH2O. FiO2 in both groups was set to maintain 88% -92% peripheral blood oxygen saturation.
The study group was treated with nasal high-flow oxygen therapy combined with sequential non-invasive ventilation. Patients will receive high-flow oxygen therapy ventilator during the day and in the morning and evening awake time (manufacturer: Hunan Mingkang Zhongjin Medical Technology Co., Ltd., registration number: Xiangji Zhuzhun 20192080049, model: OH60A) treatment. At night (from 10 p.m. to 6
NIV routine treatmentDevice
Usually, the ventilator was set to the pressure support ventilation mode, and the inspiratory pressure was adjusted to the maximum tolerance to obtain the ideal body weight of 6 ~ 8mL / kg of exhaled tidal volume, and the PEEP was set at 3 ~ 5cmH2O. FiO2 in both groups was set to maintain 88% -92% peripheral blood oxygen saturation.

Study groups in NCT06992479
Study group	Role	What they receive
HFNC combined with sequential NIV therapy group	Experimental	Not described Receives: Device: high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV)
NIV therapy group	Active comparator	Not described Receives: Device: NIV routine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

arterial blood gas indexes
Measured: before and after 7 days of BiPAP treatment
the first second forced expiratory volume
Measured: before and after 7 days of BiPAP treatment
forced vital capacity
Measured: before and after 7 days of BiPAP treatment
FEV1 / FVC
Measured: before and after 7 days of BiPAP treatment
FEV1 / predicted value
Measured: before and after 7 days of BiPAP treatment
PEF / predicted value
Measured: before and after 7 days of BiPAP treatment
heart rate
Measured: before and after 7 days of BiPAP treatment
respiratory rate
Measured: before and after 7 days of BiPAP treatment
blood pressure
Measured: before and after 7 days of BiPAP treatment
Quality of life
SF-36 comprehensively summarized the quality of life of respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health. The score range is 0-100. The higher the score, the better the situation.
Measured: before and after 7 days of BiPAP treatment
Complications
Measured: before and after 7 days of BiPAP treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202131 Jan 2024

First posted28 May 2025
Study start1 Jan 2021
Primary completion1 Jan 2024
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06992479
Sponsor's protocol ID: LL-2023-052-K
Status last verified: May 2025
First submitted: 12 May 2025
Last updated: 28 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Nasal High-flow Oxygen Therapy Combined With Sequential Non-invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Complicated With Type II Respiratory Failure
ClinicalTrials.gov ID: NCT06992479
Acronym / sponsor ID: LL-2023-052-K
Conditions: Chronic Obstructive Pulmonary Disease (COPD), Nasal High Flow Oxygen Therapy, Noninvasive Ventilation, Respiratory Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Beijing YouAn HospitalUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 1 Jan 2024 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 28 May 2025 (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.

Participants will:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
HFNC combined with sequential NIV therapy group	Experimental	Device: high-flow nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV)
NIV therapy group	Active comparator	Device: NIV routine treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

All subjects included in the study met the diagnostic criteria for AECOPD in the Global Initiative for Chronic Obstructive Pulmonary Disease (2014 Update);
Age > 18 years old;
All patients met the diagnostic criteria for type II respiratory failure in the eighth edition of ' Internal Medicine ', that was, arterial blood PaO2 < 50mmHg;
The patient was conscious, without myocardial infarction, acute stroke, severe liver and kidney dysfunction, severe coagulation dysfunction and other diseases;
The patient did not have life-threatening hypoxemia and severe hemodynamic instability, and did not need tracheal intubation or tracheotomy;

Key exclusion criteria (7 listed)

Patients with pneumothorax, mediastinal emphysema or severe thoracic deformity;
Patients with bronchial asthma, interstitial pneumonia and other diseases;
Patients with coma and disturbance of consciousness;
The upper respiratory tract or facial injury and facial deformity, can not wear a good nose (face) mask;
Patients with septic shock or severe heart, kidney, liver and other diseases;

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 nasal cannula oxygen therapy (HFNC) combined with sequential non-invasive ventilation (NIV)The control group was treated with NIV routine treatment. During non-invasive ventilation, patients in both the intervention group and the conventional group will receive NIV through a full mask or nasal mask using any of the existing ventilators in the hospital. Usually, the ventilator was set to the pressure support ventilation mode, and the inspiratory pressure was adjusted to the maximum tolerance to obtain the ideal body weight of 6 ~ 8mL / kg of exhaled tidal volume, and the PEEP was set at 3 ~ 5cmH2O. FiO2 in both groups was set to maintain 88% -92% peripheral blood oxygen saturation. The study group was treated with nasal high-flow oxygen therapy combined with sequential non-invasive ventilation. Patients will receive high-flow oxygen therapy ventilator during the day and in the morning and evening awake time (manufacturer: Hunan Mingkang Zhongjin Medical Technology Co., Ltd., registration number: Xiangji Zhuzhun 20192080049, model: OH60A) treatment. At night (from 10 p.m. to 6	Device	HFNC combined with sequential NIV therapy group
NIV routine treatmentUsually, the ventilator was set to the pressure support ventilation mode, and the inspiratory pressure was adjusted to the maximum tolerance to obtain the ideal body weight of 6 ~ 8mL / kg of exhaled tidal volume, and the PEEP was set at 3 ~ 5cmH2O. FiO2 in both groups was set to maintain 88% -92% peripheral blood oxygen saturation.	Device	NIV therapy group

Primary outcome

arterial blood gas indexes
Time frame: before and after 7 days of BiPAP treatment
the first second forced expiratory volume
Time frame: before and after 7 days of BiPAP treatment
forced vital capacity
Time frame: before and after 7 days of BiPAP treatment
FEV1 / FVC
Time frame: before and after 7 days of BiPAP treatment
FEV1 / predicted value
Time frame: before and after 7 days of BiPAP treatment
PEF / predicted value
Time frame: before and after 7 days of BiPAP treatment
heart rate
Time frame: before and after 7 days of BiPAP treatment
respiratory rate
Time frame: before and after 7 days of BiPAP treatment
blood pressure
Time frame: before and after 7 days of BiPAP treatment
Quality of life
Time frame: before and after 7 days of BiPAP treatment
SF-36 comprehensively summarized the quality of life of respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health. The score range is 0-100. The higher the score, the better the situation.
Complications
Time frame: before and after 7 days of BiPAP treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Individual participant dataSharing planned: No

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 28 May 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

arterial blood gas indexes (time frame: before and after 7 days of BiPAP treatment). The study lists 11 primary outcomes in all. 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 NCT06992479.

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 May 2025.