Clinical trial NCT02499718: Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease
Official title: Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
name: Second Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Dongguan People's Hospital
First posted: 2015-07-16
Enrollment: 368
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Severe Respiratory Insufficiency (SRI) Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Blood gas analysis
timeFrame: 1 year
measure: Pulmanory function
timeFrame: 1 year
measure: Baseline Dyspnea Index/Transition Dyspnea Index
timeFrame: 1 year
measure: Chromic Respiratory Questionnaire
timeFrame: 1 year
measure: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test
timeFrame: 1 year
measure: 6 Minute-Walking Distance and Borg Score
timeFrame: 1 year
measure: The frequency of exacerbation
timeFrame: 1 year
measure: The frequency of readmission
timeFrame: 1 year
measure: The frequency of ICU readmission
timeFrame: 1 year
measure: survival rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
References:
citation: Chen R, Guan L, Wu W, Yang Z, Li X, Luo Q, Liang Z, Wang F, Guo B, Huo Y, Yang Y, Zhou L. The Chinese version of the Severe Respiratory Insufficiency questionnaire for patients with chronic hypercapnic chronic obstructive pulmonary disease receiving non-invasive positive pressure ventilation. BMJ Open. 2017 Aug 28;7(8):e017712. doi: 10.1136/bmjopen-2017-017712.
citation: Zhou L, Li X, Guan L, Chen J, Guo B, Wu W, Huo Y, Zhou Z, Liang Z, Zhou Y, Tan J, Chen X, Song Y, Chen R. Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial. Int J Chron Obstruct Pulmon Dis. 2017 Apr 27;12:1279-1286. doi: 10.2147/COPD.S127540. eCollection 2017.