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

Guangzhou Medical University

Status: Unknown

Conditions: Hypercapnic Respiratory Failure; COPD

Treatments: Device: Noninvasive positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03238014

GIRD201707

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

14 participants in 2 patient groups

High-intensity noninvasive ventilation

Experimental group

Description:

High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.

Treatment:

Device: Noninvasive positive pressure ventilation

Low-intensity noninvasive ventilation

Active Comparator group

Description:

Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.

Treatment:

Device: Noninvasive positive pressure ventilation