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Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)

Sponsor
Kyoto University, Graduate School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00905476
Collaborator
Ministry of Health, Labour and Welfare, Japan (Other)
56
Enrollment
11
Locations
67
Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Actual Enrollment :
    56 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    NPPV

    Patients with chronic respiratory failure receiving domiciliary NPPV

    Outcome Measures

    Primary Outcome Measures

    1. Prognosis/Mortality [3 years]

    Secondary Outcome Measures

    1. Health status [At entry and every year for 3 years]

    2. Dyspnea [At entry and every year for 3 years]

    3. Psychological status [At entry and every year for 3 years]

    4. Sleep quality [At entry and every year for 3 years]

    5. Pulmonary function [At entry and every year for 3 years]

    6. Arterial blood gas [At entry and every year for 3 years]

    7. 6 minute walking tests [At entry and every year for 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NHO Minami-Kyoto Hospital Joyo Japan 610-0113
    2 Kobe City Hospital Organization Medical Center West Hospital Kobe Japan
    3 Kobe City Medical Center General Hospital Kobe Japan
    4 Komaki Municipal Hospital Komaki Japan
    5 Graduate School of Medicine, Kyoto University Kyoto Japan 6068507
    6 Ogaki Municipal Hospital Ogaki Japan
    7 Otsu Red Cross Hospital Otsu Japan
    8 Tosei General Hospital Seto Japan
    9 Takatsuki Red Cross Hospital Takatsuki Japan
    10 Tenri Hospital Tenri Japan
    11 NHO Toneyama National Hospital Toyonaka Japan

    Sponsors and Collaborators

    • Kyoto University, Graduate School of Medicine
    • Ministry of Health, Labour and Welfare, Japan

    Investigators

    • Study Chair: Kazuo Chin, M.D., Graduate School of Medicine, Kyoto University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine
    ClinicalTrials.gov Identifier:
    NCT00905476
    Other Study ID Numbers:
    • E552kyoto
    First Posted:
    May 20, 2009
    Last Update Posted:
    Apr 3, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine
    NPPV
    Prognosis
    Health-related quality of life
    Patient reported outcomes
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Apr 3, 2015