Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity noninvasive ventilation | Experimental | High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2. |
|
| Low-intensity noninvasive ventilation | Active Comparator | Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive positive pressure ventilation | Device | Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease. |
|
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lili Guan | Contact | +8613422288665 | dr_nickguan@163.com | |
| Luqian Zhou | Contact | +8613826098411 | icelucy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Rongchang Chen | Guangzhou Institute of Respiratory Disease | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease | Recruiting | Guangzhou | Guangdong | 510000 | China |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |