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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 April 2013
Main ID:  NCT00905476
Date of registration: 18/05/2009
Primary sponsor: Kyoto University, Graduate School of Medicine
Public title: Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)
Scientific title: Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV
Date of first enrolment: April 2009
Target sample size: 120
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00905476
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
Japan
Contacts
Name:   Toru Oga, M.D.
Address: 
Telephone: +81 75 751 3852
Email:
Affiliation: 
Name:   Toru Oga, M.D.
Address: 
Telephone: +81 75 751 3852
Email: ogato@kuhp.kyoto-u.ac.jp
Affiliation: 
Name:   Kazuo Chin, M.D.
Address: 
Telephone:
Email:
Affiliation:  Graduate School of Medicine, Kyoto University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with chronic respiratory failure receiving domiciliary NPPV for more than 3
months

Exclusion Criteria:

- Uncontrolled severe comorbidities

- Patients with tracheotomy.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Respiratory Failure
Intervention(s)
Primary Outcome(s)
Prognosis/Mortality [Time Frame: 3 years]
Secondary Outcome(s)
6 minute walking tests [Time Frame: At entry and every year for 3 years]
Arterial blood gas [Time Frame: At entry and every year for 3 years]
Dyspnea [Time Frame: At entry and every year for 3 years]
Health status [Time Frame: At entry and every year for 3 years]
Psychological status [Time Frame: At entry and every year for 3 years]
Pulmonary function [Time Frame: At entry and every year for 3 years]
Sleep quality [Time Frame: At entry and every year for 3 years]
Secondary ID(s)
E552kyoto
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, Labour and Welfare, Japan
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