Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Treatments: Device: BiPAP mode

Study type: Interventional

Funder types: Other

Identifiers

NCT02499718

GRID-201506

Details and patient eligibility

About

Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease

Enrollment: 368 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.

Exclusion criteria

• thorax or the lung other than COPD
• No smoking or Cigarette≤10/day
• obesity with a bodymass index (BMI) ≥40 kg/m²
• malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups

Noninvasive ventilator

Experimental group

Description:

noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Treatment:

Device: BiPAP mode

LTOT

No Intervention group

Description:

long-term oxygen therapy for severe stable chronic obstructive pulmonary disease