Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD
- Conditions
- COPDHypercapnic Respiratory Failure
- Interventions
- Device: Noninvasive positive pressure ventilation
- Registration Number
- NCT03238014
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low-intensity noninvasive ventilation Noninvasive positive pressure ventilation Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation. High-intensity noninvasive ventilation Noninvasive positive pressure ventilation High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Chromic Respiratory Questionnaire 12 weeks Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.
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.
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.
Trial Locations
- Locations (1)
Guangzhou Institute of Respiratory Disease
🇨🇳Guangzhou, Guangdong, China