UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011066 |
|---|---|
| Receipt number | R000012948 |
| Scientific Title | An observational study of ambulatory pulse oximetry monitoring in chronic obstructive pulmonary disease outpatients not receiving supplemental oxygen therapy |
| Date of disclosure of the study information | 2013/06/28 |
| Last modified on | 2013/06/28 15:43:55 |
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Basic information
Public title
An observational study of ambulatory pulse oximetry monitoring in chronic obstructive pulmonary disease outpatients not receiving supplemental oxygen therapy
Acronym
A study of pulse oximetry monitoring in COPD outpatients
Scientific Title
An observational study of ambulatory pulse oximetry monitoring in chronic obstructive pulmonary disease outpatients not receiving supplemental oxygen therapy
Scientific Title:Acronym
A study of pulse oximetry monitoring in COPD outpatients
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to analyse the desaturation profiles of Japanese COPD outpatients not receiving supplemental oxygen therapy during daily living activities at home using continuous 24-hour pulse oximetry for the purpose of evaluating the prevalence of desaturation and the relationship between desaturation profile and clinical characteristics of COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of desaturators, defined as patients who spent more than 30% of the oximetry period with SpO2 < 90%.
Key secondary outcomes
Mean SpO2 level and heart rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Portable pulse oximeter (PULSOX-Me300; Konica-Minolta, Tokyo, Japan) were used to obtain continuous oximetry data over a 24-hour period. Each patient was instructed on the proper use of the portable oximeter before monitoring began. All data were downloaded to a computer for analysis (DS-Me version 2.10). Patients were instructed to keep an activity log in which they recorded the time of their major daily activities. Patients were encouraged to perform all normal daily ambulatory activities, and not to alter their baseline levels of daily physical activity.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) clinically stable COPD according to the Global Initiative on Obstructive Lung Disease (GOLD) staging
(2) the ability to walk independently or with a cane
(3) sufficient cognitive function to follow the instructions for using the pulse oximetry equipment.
(4) written informed consent
Key exclusion criteria
(1) inpatients
(2) patients who experienced recent episodes of exacerbation requiring hospitalization or administration of antibiotics or steroids in the previous 3 months
(3) other significant respiratory diseases or medical problems precluding ambulatory activity at home
(4) patients who were undergoing treatment with supplemental oxygen therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Komuta |
Organization
Osaka Police Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL
81-6-6771-6051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Police Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Respiratory Medicine, Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Osaka Police Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 06 | Month | 28 | 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
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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 28 | Day |
Last modified on
| 2013 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012948
