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Clinical Trials/NCT00905476
NCT00905476
Completed
Not Applicable

Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV

Kyoto University, Graduate School of Medicine11 sites in 1 country56 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Respiratory Failure
Sponsor
Kyoto University, Graduate School of Medicine
Enrollment
56
Locations
11
Primary Endpoint
Prognosis/Mortality
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purposes of the present study are (1) to analyze baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors, and (3) to examine longitudinal clinical course in patients with chronic respiratory failure receiving domiciliary NPPV.

Detailed Description

Limited data are available about the prognosis and its predictive factors in patients with chronic respiratory failure receiving domiciliary NPPV. In addition, their health status, psychological status and sleep quality seem to be highly disturbed due to severe respiratory insufficiency. Therefore, in the present study, we aim to examine (1) contributive factors to health status based on baseline data, (2) whether patient reported measurements such as health status, dyspnea and psychological status would predict patient's future outcomes, and (3) how they would change for 3 years as compared to physiological measurements.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
November 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kyoto University, Graduate School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Toru Oga

Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Kyoto University, Graduate School of Medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Uncontrolled severe comorbidities
  • Patients with tracheotomy.

Outcomes

Primary Outcomes

Prognosis/Mortality

Time Frame: 3 years

Secondary Outcomes

  • Psychological status(At entry and every year for 3 years)
  • Pulmonary function(At entry and every year for 3 years)
  • Arterial blood gas(At entry and every year for 3 years)
  • Dyspnea(At entry and every year for 3 years)
  • Health status(At entry and every year for 3 years)
  • 6 minute walking tests(At entry and every year for 3 years)
  • Sleep quality(At entry and every year for 3 years)

Study Sites (11)

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