CompletedNot Applicable

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

China100 participantsStarted 2021-01-01

Plain-language 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. The main questions it aims to answer are: 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 patient…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

arterial blood gas indexes

Timeframe: before and after 7 days of BiPAP treatment

the first second forced expiratory volume

Timeframe: before and after 7 days of BiPAP treatment

forced vital capacity

Timeframe: before and after 7 days of BiPAP treatment

FEV1 / FVC

Timeframe: before and after 7 days of BiPAP treatment

FEV1 / predicted value

Timeframe: before and after 7 days of BiPAP treatment

PEF / predicted value

Timeframe: before and after 7 days of BiPAP treatment

heart rate

Timeframe: before and after 7 days of BiPAP treatment

Trial details

NCT IDNCT06992479

SponsorBeijing YouAn Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease (COPD) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

arterial blood gas indexes

Timeframe: before and after 7 days of BiPAP treatment

the first second forced expiratory volume

Timeframe: before and after 7 days of BiPAP treatment

forced vital capacity

Timeframe: before and after 7 days of BiPAP treatment

FEV1 / FVC

Timeframe: before and after 7 days of BiPAP treatment

FEV1 / predicted value

Timeframe: before and after 7 days of BiPAP treatment

PEF / predicted value

Timeframe: before and after 7 days of BiPAP treatment

heart rate

Timeframe: before and after 7 days of BiPAP treatment