Back to resultsNon-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BiPAP mode
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Non-invasive positive pressure ventilation, quality of life, long-term oxygen therapy
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.
Sites / Locations
- Guangzhou Institute of Respiratory DiseaseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Noninvasive ventilator
LTOT
Arm Description
noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease
long-term oxygen therapy for severe stable chronic obstructive pulmonary disease
Outcomes
Primary Outcome Measures
Severe Respiratory Insufficiency (SRI) Questionnaire
Secondary Outcome Measures
Blood gas analysis
Pulmanory function
Baseline Dyspnea Index/Transition Dyspnea Index
Chromic Respiratory Questionnaire
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test
6 Minute-Walking Distance and Borg Score
The frequency of exacerbation
The frequency of readmission
The frequency of ICU readmission
survival rate
Full Information
NCT ID
NCT02499718
First Posted
June 9, 2015
Last Updated
July 15, 2015
Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Southern Medical University, China, Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Dongguan People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02499718
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Southern Medical University, China, Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Dongguan People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Keywords
Chronic Obstructive Pulmonary Disease, Non-invasive positive pressure ventilation, quality of life, long-term oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Noninvasive ventilator
Arm Type
Experimental
Arm Description
noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease
Arm Title
LTOT
Arm Type
No Intervention
Arm Description
long-term oxygen therapy for severe stable chronic obstructive pulmonary disease
Intervention Type
Device
Intervention Name(s)
BiPAP mode
Intervention Description
Noninvasive ventilator
Primary Outcome Measure Information:
Title
Severe Respiratory Insufficiency (SRI) Questionnaire
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood gas analysis
Time Frame
1 year
Title
Pulmanory function
Time Frame
1 year
Title
Baseline Dyspnea Index/Transition Dyspnea Index
Time Frame
1 year
Title
Chromic Respiratory Questionnaire
Time Frame
1 year
Title
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test
Time Frame
1 year
Title
6 Minute-Walking Distance and Borg Score
Time Frame
1 year
Title
The frequency of exacerbation
Time Frame
1 year
Title
The frequency of readmission
Time Frame
1 year
Title
The frequency of ICU readmission
Time Frame
1 year
Title
survival rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou LuQian, Doctor
Phone
+86-15622236759
Email
zhlx09@163.com
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Rongchang, Doctor
Phone
+8613902273260
Email
icelucy@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28851800
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.
Results Reference
derived
PubMed Identifier
28490871
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.
Results Reference
derived
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Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease
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