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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Nasal High Flow Oxygen Therapy; Noninvasive Ventilation; Respiratory Failure

• Registration Number: NCT06992479
• Lead Sponsor: Beijing YouAn Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life	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	before and after 7 days of BiPAP treatment
arterial blood gas indexes	before and after 7 days of BiPAP treatment
the first second forced expiratory volume	before and after 7 days of BiPAP treatment
forced vital capacity	before and after 7 days of BiPAP treatment
FEV1 / FVC	before and after 7 days of BiPAP treatment
FEV1 / predicted value	before and after 7 days of BiPAP treatment
PEF / predicted value	before and after 7 days of BiPAP treatment
heart rate	before and after 7 days of BiPAP treatment
respiratory rate	before and after 7 days of BiPAP treatment
blood pressure	before and after 7 days of BiPAP treatment

Trial Locations

Locations (1)

Beijing You'an Hospital, Capital Medical University; 🇨🇳 Beijing, China