NCT00905476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

5.6 years

First QC Date

May 18, 2009

Last Update Submit

April 1, 2015

Conditions

Keywords

NPPVPrognosisHealth-related quality of lifePatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Prognosis/Mortality

    3 years

Secondary Outcomes (7)

  • Health status

    At entry and every year for 3 years

  • Dyspnea

    At entry and every year for 3 years

  • Psychological status

    At entry and every year for 3 years

  • Sleep quality

    At entry and every year for 3 years

  • Pulmonary function

    At entry and every year for 3 years

  • +2 more secondary outcomes

Study Arms (1)

NPPV

Patients with chronic respiratory failure receiving domiciliary NPPV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient clinic of respiratory medicine

You may qualify if:

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

You may not qualify if:

  • Uncontrolled severe comorbidities
  • Patients with tracheotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

NHO Minami-Kyoto Hospital

Jōyō, 610-0113, Japan

Location

Kobe City Hospital Organization Medical Center West Hospital

Kobe, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Japan

Location

Komaki Municipal Hospital

Komaki, Japan

Location

Graduate School of Medicine, Kyoto University

Kyoto, 6068507, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Japan

Location

Otsu Red Cross Hospital

Ōtsu, Japan

Location

Tosei General Hospital

Seto, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki, Japan

Location

Tenri Hospital

Tenri, Japan

Location

NHO Toneyama National Hospital

Toyonaka, Japan

Location

Related Publications (1)

  • 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.

Study Officials

  • Kazuo Chin, M.D.

    Graduate School of Medicine, Kyoto University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations