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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02240225
Other study ID # GZIRD-20140910
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2014
Last updated September 11, 2014
Start date January 2014
Est. completion date October 2014

Study information

Verified date September 2014
Source Guangzhou Institute of Respiratory Disease
Contact Zhou LuQian, Doctor
Phone +86-15622236759
Email zhlx09@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

Assessment of health-related quality of life in COPD patients with severe chronic respiratory failure requires appropriate and highly specific measurement tools. We attempt to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Adult COPD Patients with chronic hypercapnic respiratory failure established on home noninvasive ventilation for at least 1 month

2. Patients are in a clinically stable state,without any changes of medication during the previous 4 weeks.

Exclusion Criteria:

1. patient's refusal to participate

2. Patients with evidence of acute respiratory failure i.e.patients with worsening of symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory infection

Study Design

Time Perspective: Prospective


Locations

Country Name City State
China Guangzhou Institute of Respiratory Disease Guangzhou Guangdong

Sponsors (7)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease Dongguan People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, Shaoguan People's Hospital, Southern Medical University, China, The center hospital of Wuhan, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reliability of Severe Respiratory Insufficiency Questionnaire 2 weeks No
Secondary Construct validity of Severe Respiratory Insufficiency Questionnaire 2 weeks No
Secondary Criterion validity of Severe Respiratory Insufficiency Questionnaire 2 weeks No
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