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

Chronic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905476
• Other study ID #: E552kyoto
• Status: Completed
• Phase: N/A
• First received: May 18, 2009
• Last updated: April 1, 2015
• Start date: April 2009
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Uncontrolled severe comorbidities

• Patients with tracheotomy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
Japan	NHO Minami-Kyoto Hospital	Joyo
Japan	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	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

Sponsors (2)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis/Mortality		3 years	No
Secondary	Health status		At entry and every year for 3 years	No
Secondary	Dyspnea		At entry and every year for 3 years	No
Secondary	Psychological status		At entry and every year for 3 years	No
Secondary	Sleep quality		At entry and every year for 3 years	No
Secondary	Pulmonary function		At entry and every year for 3 years	No
Secondary	Arterial blood gas		At entry and every year for 3 years	No
Secondary	6 minute walking tests		At entry and every year for 3 years	No