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

July 15, 2015 updated by: LuQian Zhou, Guangzhou Institute of Respiratory Disease

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangzhou Institute of Respiratory Disease
        • Contact:
          • Chen Rongchang, Doctor
          • Phone Number: +8613902273260
          • Email: icelucy@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Noninvasive ventilator
noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease
Device: BiPAP mode
Noninvasive ventilator
NO_INTERVENTION: LTOT
long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Second Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (ESTIMATE)

July 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRID-201506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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