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

Overview

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

Full Title of Study: “Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Interventions

  • Device: BiPAP mode
    • Noninvasive ventilator

Arms, Groups and Cohorts

  • Experimental: Noninvasive ventilator
    • noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease
  • No Intervention: LTOT
    • long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Clinical Trial Outcome Measures

Primary Measures

  • Severe Respiratory Insufficiency (SRI) Questionnaire
    • Time Frame: 1 year

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou Institute of Respiratory Disease
  • Collaborator
    • Southern Medical University, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: LuQian Zhou, Assistant Professor of Guangzhou Institute of Respiratory Disease – Guangzhou Institute of Respiratory Disease
  • Overall Contact(s)
    • Zhou LuQian, Doctor, +86-15622236759, zhlx09@163.com

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