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

April 1, 2015 updated by: Toru Oga, Kyoto University, Graduate School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Joyo, Japan, 610-0113
        • NHO Minami-Kyoto Hospital
      • Kobe, Japan
        • Kobe City Medical Center General Hospital
      • Kobe, Japan
        • Kobe City Hospital Organization Medical Center West Hospital
      • Komaki, Japan
        • Komaki Municipal Hospital
      • Kyoto, Japan, 6068507
        • Graduate School of Medicine, Kyoto University
      • Ogaki, Japan
        • Ogaki Municipal Hospital
      • Otsu, Japan
        • Otsu Red Cross Hospital
      • Seto, Japan
        • Tosei General Hospital
      • Takatsuki, Japan
        • Takatsuki Red Cross Hospital
      • Tenri, Japan
        • Tenri Hospital
      • Toyonaka, Japan
        • NHO Toneyama National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatient clinic of respiratory medicine

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled severe comorbidities
  • Patients with tracheotomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NPPV
Patients with chronic respiratory failure receiving domiciliary NPPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prognosis/Mortality
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Health status
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years
Dyspnea
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years
Psychological status
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years
Sleep quality
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years
Pulmonary function
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years
Arterial blood gas
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years
6 minute walking tests
Time Frame: At entry and every year for 3 years
At entry and every year for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E552kyoto

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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