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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02499718
Enrollment
368
Registered
2015-07-16
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Keywords

Chronic Obstructive Pulmonary Disease, Non-invasive positive pressure ventilation, quality of life, long-term oxygen therapy

Brief summary

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

Interventions

DEVICEBiPAP mode

Noninvasive ventilator

Sponsors

Southern Medical University, China
CollaboratorOTHER
Second Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Third Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Dongguan People's Hospital
CollaboratorOTHER_GOV
Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Severe Respiratory Insufficiency (SRI) Questionnaire1 year

Secondary

MeasureTime frame
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test1 year
6 Minute-Walking Distance and Borg Score1 year
The frequency of exacerbation1 year
The frequency of readmission1 year
Chromic Respiratory Questionnaire1 year
survival rate1 year
Baseline Dyspnea Index/Transition Dyspnea Index1 year
Blood gas analysis1 year
Pulmanory function1 year
The frequency of ICU readmission1 year

Countries

China

Contacts

Primary ContactZhou LuQian, Doctor
zhlx09@163.com+86-15622236759

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026