Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)
This study is currently recruiting participants.
Verified March 2013 by Kyoto University, Graduate School of Medicine
Sponsor:
Kyoto University, Graduate School of Medicine
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
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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
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 May 16, 2013