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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure
• Interventions: Device: BiPAP mode

• Registration Number: NCT02499718
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-06-09
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 368

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilator	BiPAP mode	noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Primary Outcome Measures

Name	Time	Method
Severe Respiratory Insufficiency (SRI) Questionnaire	1 year

Secondary Outcome Measures

Name	Time	Method
Baseline Dyspnea Index/Transition Dyspnea Index	1 year
Chromic Respiratory Questionnaire	1 year
The frequency of readmission	1 year
Pulmanory function	1 year
6 Minute-Walking Distance and Borg Score	1 year
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test	1 year
Blood gas analysis	1 year
The frequency of exacerbation	1 year
The frequency of ICU readmission	1 year
survival rate	1 year

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China