COPD, Hypercapnic Respiratory Failure
Conditions
Brief summary
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.
Interventions
Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial pressure of arterial blood carbon dioxide (PaCO2) | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Respiratory Insufficiency (SRI) Questionnaire | 12 weeks | 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. |
| Baseline Dyspnea Index/Transition Dyspnea Index | 12 weeks | 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. |
| Pulmonary function | 12 weeks | Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc. |
| COPD assessment test | 12 weeks | 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. |
| 6-minute walk test | 12 weeks | 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. |
| Chromic Respiratory Questionnaire | 12 weeks | Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease. |
Countries
China
Contacts
Primary ContactLili Guan
Backup ContactLuqian Zhou
Outcome results
None listed