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Clinical Trials/NCT00905476
NCT00905476CompletedNot 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 enrollmentStarted: April 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
56
Locations
11
Primary Endpoint
Prognosis/Mortality

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Kyoto University, Graduate School of Medicine
Sponsor Class
Other
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

Study Sites (11)

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