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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Kyoto University, Graduate School of Medicine
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00905476
First received: May 18, 2009
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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
Chronic Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Prognosis/Mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health status [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]
  • Dyspnea [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]
  • Psychological status [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]
  • Pulmonary function [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]
  • Arterial blood gas [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]
  • 6 minute walking tests [ Time Frame: At entry and every year for 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
NPPV
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatient clinic of respiratory medicine

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905476

Contacts
Contact: Toru Oga, M.D. +81 75 751 3852 ogato@kuhp.kyoto-u.ac.jp
Contact: Tomomasa Tsuboi, M.D. +81 75 751 3852 tomomasa@kuhp.kyoto-u.ac.jp

Locations
Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Recruiting
Habikino, Japan
Principal Investigator: Hideki Ishihara, M.D.         
National Hospital Organization Himeji Medical Center Recruiting
Himeji, Japan
Principal Investigator: Yoshiro Miochizuki, M.D.         
Kobe City Medical Center General Hospital Recruiting
Kobe, Japan
Principal Investigator: Keisuke Tomii, M.D.         
Kobe City Hospital Organization Medical Center West Hospital Recruiting
Kobe, Japan
Principal Investigator: Hiromi Tomii, M.D.         
Komaki Municipal Hospital Recruiting
Komaki, Japan
Principal Investigator: Tetsuo Hiramatsu, M.D.         
Graduate School of Medicine, Kyoto University Recruiting
Kyoto, Japan, 6068507
Contact: Toru Oga, M.D.    +81 75 751 3852      
Contact: Tomomasa Tsuboi, M.D.    +81 75 751 3852      
Otsu Red Cross Hospital Recruiting
Otsu, Japan
Principal Investigator: Naoki Sakai, M.D.         
Sub-Investigator: Kenichi Takahashi, M.D.         
Tosei General Hospital Recruiting
Seto, Japan
Principal Investigator: Hiroyuki Taniguchi, M.D.         
Sub-Investigator: Tomoki Kimura, M.D.         
Takatsuki Red Cross Hospital Recruiting
Takatsuki, Japan
Principal Investigator: Hideo Kita, M.D.         
Tenri Hospital Recruiting
Tenri, Japan
Principal Investigator: Yoshio Taguchi, M.D.         
NHO Toneyama National Hospital Recruiting
Toyonaka, Japan
Principal Investigator: Ryoji Maekura, M.D.         
Sub-Investigator: Toru Hiraga, M.D.         
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
  More Information

No publications 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     History of Changes
Other Study ID Numbers: E552kyoto
Study First Received: May 18, 2009
Last Updated: March 25, 2013
Health Authority: Japan: Ethical Committee

Keywords provided by Kyoto University, Graduate School of Medicine:
NPPV
Prognosis
Health-related quality of life
Patient reported outcomes

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014