Validation of Chinese SRI Questionnaire

Chronic Obstructive Pulmonary Disease Clinical Trial

— VCSRI  

Official title:

Validation of Chinese Severe Respiratory Insufficiency （SRI）Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02240225
• Other study ID #: GZIRD-20140910
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Respiratory Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

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