Chronic Respiratory FailureNCT00905476
Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)
An observational study of Chronic Respiratory Failure, run by Kyoto University, Graduate School of Medicine at 11 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- How many people
- 56 participants
- Where
- 11 sitesJapan
- Study dates
- Apr 2009to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic of respiratory medicine
Who may be able to join
- Patients with chronic respiratory failure receiving domiciliary NPPV for more than 3 months
Who cannot join
- Uncontrolled severe comorbidities
- Patients with tracheotomy.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
NHO Minami-Kyoto Hospital
Jōyō, 610-0113
Kobe City Hospital Organization Medical Center West Hospital
Kobe
Kobe City Medical Center General Hospital
Kobe
Komaki Municipal Hospital
Komaki
Graduate School of Medicine, Kyoto University
Kyoto, 6068507
Ogaki Municipal Hospital
Ōgaki
Otsu Red Cross Hospital
Ōtsu
Tosei General Hospital
Seto
Takatsuki Red Cross Hospital
Takatsuki
Tenri Hospital
Tenri
NHO Toneyama National Hospital
Toyonaka
About this study
Official title: Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV
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.
Read the 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.
- Conditions
- Chronic Respiratory Failure
- Keywords
- NPPV, Prognosis, Health-related quality of life, Patient reported outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NPPV | Patients with chronic respiratory failure receiving domiciliary NPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis/Mortality
Measured: 3 years
Secondary outcomes (7)
Health status
Measured: At entry and every year for 3 years
Dyspnea
Measured: At entry and every year for 3 years
Psychological status
Measured: At entry and every year for 3 years
Sleep quality
Measured: At entry and every year for 3 years
Pulmonary function
Measured: At entry and every year for 3 years
Arterial blood gas
Measured: At entry and every year for 3 years
6 minute walking tests
Measured: At entry and every year for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Principal investigator, Toru Oga, Kyoto University, Graduate School of Medicine
- Investigators
- Kazuo Chin, M.D., Study chair, Graduate School of Medicine, Kyoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905476
- Sponsor's protocol ID
- E552kyoto
- Status last verified
- Apr 2015
- First submitted
- 18 May 2009
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28588383
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV
- ClinicalTrials.gov ID
- NCT00905476
- Acronym / sponsor ID
- E552kyoto
- Conditions
- Chronic Respiratory Failure
- Keywords
- NPPV, Prognosis, Health-related quality of life, Patient reported outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Apr 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPPV | – | –Patients with chronic respiratory failure receiving domiciliary NPPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic of respiratory medicine
Key inclusion criteria (1 listed)
- Patients with chronic respiratory failure receiving domiciliary NPPV for more than 3 months
Key exclusion criteria (2 listed)
- Uncontrolled severe comorbidities
- Patients with tracheotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognosis/Mortality
Time frame: 3 years
7 secondary outcomes
Health status
Time frame: At entry and every year for 3 years
Dyspnea
Time frame: At entry and every year for 3 years
Psychological status
Time frame: At entry and every year for 3 years
Sleep quality
Time frame: At entry and every year for 3 years
Pulmonary function
Time frame: At entry and every year for 3 years
Arterial blood gas
Time frame: At entry and every year for 3 years
6 minute walking tests
Time frame: At entry and every year for 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 28588383Oga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuo Chin, M.D. study chair
Graduate School of Medicine, Kyoto University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure, run by Kyoto University, Graduate School of Medicine at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis/Mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00905476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.