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Clinical Trials/NCT02499718
NCT02499718
Unknown
Not Applicable

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

Guangzhou Institute of Respiratory Disease1 site in 1 country368 target enrollmentJanuary 2014
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ConditionsChronic Obstructive Pulmonary DiseaseHypercapnic Respiratory Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Guangzhou Institute of Respiratory Disease
Enrollment
368
Locations
1
Primary Endpoint
Severe Respiratory Insufficiency (SRI) Questionnaire
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Institute of Respiratory Disease
Responsible Party
Principal Investigator
Principal Investigator

LuQian Zhou

Assistant Professor of Guangzhou Institute of Respiratory Disease

Guangzhou Institute of Respiratory 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.

Outcomes

Primary Outcomes

Severe Respiratory Insufficiency (SRI) Questionnaire

Time Frame: 1 year

Secondary Outcomes

  • 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)

Study Sites (1)

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