Clinical trial NCT00905476: Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)
Official title: Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Respiratory Failure
Keywords: NPPV
Prognosis
Health-related quality of life
Patient reported outcomes
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2009-05-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient clinic of respiratory 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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Uncontrolled severe comorbidities
* Patients with tracheotomy.

Primary outcomes:
measure: Prognosis/Mortality
timeFrame: 3 years
Secondary outcomes:
measure: Health status
timeFrame: At entry and every year for 3 years
measure: Dyspnea
timeFrame: At entry and every year for 3 years
measure: Psychological status
timeFrame: At entry and every year for 3 years
measure: Sleep quality
timeFrame: At entry and every year for 3 years
measure: Pulmonary function
timeFrame: At entry and every year for 3 years
measure: Arterial blood gas
timeFrame: At entry and every year for 3 years
measure: 6 minute walking tests
timeFrame: At entry and every year for 3 years
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: NHO Minami-Kyoto Hospital
city: Kobe
country: Japan
facility: Kobe City Hospital Organization Medical Center West Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Komaki
country: Japan
facility: Komaki Municipal Hospital
city: Kyoto
country: Japan
facility: Graduate School of Medicine, Kyoto University
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Otsu
country: Japan
facility: Otsu Red Cross Hospital
city: Seto
country: Japan
facility: Tosei General Hospital
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
city: Tenri
country: Japan
facility: Tenri Hospital
city: Toyonaka
country: Japan
facility: NHO Toneyama National Hospital
Study officials:
affiliation: Graduate School of Medicine, Kyoto University
name: Kazuo Chin, M.D.
role: STUDY_CHAIR
References:
citation: Oga T, Taniguchi H, Kita H, Tsuboi T, Tomii K, Ando M, Kojima E, Tomioka H, Taguchi Y, Kaji Y, Maekura R, Hiraga T, Sakai N, Kimura T, Mishima M, Windisch W, Chin K. Comparison of Different Disease-Specific Health-Related Quality of Life Measurements in Patients with Long-Term Noninvasive Ventilation. Can Respir J. 2017;2017:8295079. doi: 10.1155/2017/8295079. Epub 2017 May 15.