Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD

Study Overview
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Brief Summary
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High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.

Official Title
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Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease

Conditions
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COPD, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: Noninvasive positive pressure ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity noninvasive ventilation<br>High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2. | Device: Noninvasive positive pressure ventilation<br>* Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.<br>* Other names: Noninvasive ventilation;|
| Active Comparator: Low-intensity noninvasive ventilation<br>Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation. | Device: Noninvasive positive pressure ventilation<br>* Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.<br>* Other names: Noninvasive ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure of arterial blood carbon dioxide (PaCO2) | Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Respiratory Insufficiency (SRI) Questionnaire | The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NPPV. It includes 49 items on seven subscales. | 12 weeks | 
| Baseline Dyspnea Index/Transition Dyspnea Index | Baseline Dyspnea Index/Transition Dyspnea Index provides a multidimensional measurement of dyspnea based on 3 components that evoke dyspnea in activities of daily living, in symptomatic individuals. | 12 weeks | 
| Chromic Respiratory Questionnaire | Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease. | 12 weeks | 
| COPD assessment test | The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. | 12 weeks | 
| Pulmonary function | Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc. | 12 weeks | 
| 6-minute walk test | The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases. | 12 weeks |