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

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ClinicalTrials.gov Identifier: NCT00905476
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine

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
Chronic Respiratory Failure

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
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 : April 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Prognosis/Mortality [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Health status [ Time Frame: At entry and every year for 3 years ]
  2. Dyspnea [ Time Frame: At entry and every year for 3 years ]
  3. Psychological status [ Time Frame: At entry and every year for 3 years ]
  4. Sleep quality [ Time Frame: At entry and every year for 3 years ]
  5. Pulmonary function [ Time Frame: At entry and every year for 3 years ]
  6. Arterial blood gas [ Time Frame: At entry and every year for 3 years ]
  7. 6 minute walking tests [ Time Frame: At entry and every year for 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905476


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Toru Oga, 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