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

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Unknown status

CT.gov ID

NCT02499718

Collaborator

Southern Medical University, China (Other), Second Affiliated Hospital, Sun Yat-Sen University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), Dongguan People's Hospital (Other)

368

Enrollment

Location

Arms

Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure	Device: BiPAP mode	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Noninvasive ventilator noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease	Device: BiPAP mode Noninvasive ventilator
No Intervention: LTOT long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Arm

Intervention/Treatment

Experimental: Noninvasive ventilator

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

Device: BiPAP mode

Noninvasive ventilator

No Intervention: LTOT

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

Outcome Measures

Primary Outcome Measures

Severe Respiratory Insufficiency (SRI) Questionnaire [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.