UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040306 |
|---|---|
| Receipt number | R000045986 |
| Scientific Title | Actual state of constipation and its factors in patients with chronic respiratory failure |
| Date of disclosure of the study information | 2020/05/04 |
| Last modified on | 2022/05/06 10:47:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Actual state of constipation and its factors in patients with chronic respiratory failure
Acronym
Chronic respiratory failure and constipation
Scientific Title
Actual state of constipation and its factors in patients with chronic respiratory failure
Scientific Title:Acronym
Chronic respiratory failure and constipation
Region
| Japan |
Condition
Condition
Chronic respitory failure
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency and severity of constipation in patients with chronic respiratory failure, and the relationship between activity and respiratory status and constipation.
Basic objectives2
Others
Basic objectives -Others
It may be possible to clarify the need for interventions such as defecation control by investigating the occurrence of constipation and subjective symptoms associated with constipation.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Current bowel pattern and properties (Bristol scale)
Severity of constipation (Constipation Scoring System)
Effect of constipation on quality of life (JPAC-QOL)
The time when became aware of constipation
Key secondary outcomes
Existence of shortness of breath during excretion
Difficulty breathing, comfort, and security when bowel movements are good or bad (constipation) (Borg scale and VAS)
Health-related quality of life (SRI) for patients with chronic respiratory failure
Current activity
Anxiety and depression assessment (HAD)
Questionnaires such as sleep quality (PSQI) Basic diseases, age, sex, height, weight, oxygen flow rate, presence or absence of NPPV use, spirometry, 6-minute walking test, various blood test data including blood gas, constipation medication Frequency and type of medication, dosage details other than constipation medication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic respiratory failure. Underling disease do not matter (COPD, Interstitial pneumoniae, Nontuberculous mycobacteriosis, Bronchiectasis, etc.)
Previous treatment do not matter.
There is no limitation with laboratory data.
Key exclusion criteria
Clinically Unstable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Sano |
Organization
National Hospital Organization Minami Kyoto Hospital
Division name
Nursing department
Zip code
610-0113
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
kensukesumi@gmail.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
610-0113
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
Homepage URL
kensukesumi@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Minami Kyoto Hospital
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
Tel
0774-52-0065
kensukesumi@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conduct a simple questionnaire survey that is an extension of daily clinical practice.
Collect patient information from electronic medical records.
Management information
Registered date
| 2020 | Year | 05 | Month | 04 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045986
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
