UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052999 |
|---|---|
| Receipt number | R000060377 |
| Scientific Title | Development of a new oxygen delivery system combining continuous oxygen flow and demand oxygen delivery system: A prospective, single-blind, randomized crossover trial |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2025/01/22 08:52:57 |
* 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
Development of a new oxygen delivery system combining continuous oxygen flow and demand oxygen delivery system
Acronym
Development of a new oxygen delivery system combining continuous oxygen flow and demand oxygen delivery system
Scientific Title
Development of a new oxygen delivery system combining continuous oxygen flow and demand oxygen delivery system: A prospective, single-blind, randomized crossover trial
Scientific Title:Acronym
New oxygen delivery system combining continuous oxygen flow and demand oxygen delivery system
Region
| Japan |
Condition
Condition
Chronic respiratory disease and interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison efficacy of oxygen supply on oxygen saturation during walking between using conventional oxygen delivery methods (continuous oxygen and demand oxygen delivery system) and a new method (combining continuous oxygen flow and demand oxygen delivery system)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen saturation measured by pulse oximetry during 6-min walk test (assessed every 1 minute).
Key secondary outcomes
Dyspnea (modified Borg scale) and pulse rate before and after 6-min walk test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
6MWT with continuous oxygen flow,
Participants conduct three 6MWT: (1) 6MWT with continuous oxygen flow, (2) 6MWT with demand oxygen delivery system, (3) combined continuous flow oxygen and demand oxygen delivery system. The order of 6MWT with three different oxygen delivery methods was randomly defined.
Interventions/Control_2
6MWT with demand oxygen delivery system
Interventions/Control_3
6MWT with combined continuous flow oxygen and demand oxygen delivery system
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) can give written informed consent
2) diagnosed COPD according to a current guideline by Japanese Respiratory Society
3) prescribed long-term oxygen therapy due to chronic respiratory failure and use ambulatory oxygen (2L or more) in daily activity
Key exclusion criteria
1) significant comorbidities that limited walking (i.e., musculoskeletal, cardiovascular or neurological impairment)
2) significant cognitive impairment that affect study
3) acute exacerbation within 4-weeks prior to inclusion of study.
4) unable to measure SpO2 due to peripheral circulatory impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Shingai |
Organization
Nagasaki University Graduate School
Division name
Biomedical Sciences
Zip code
852-8520
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7963
k.shingai@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Shingai |
Organization
Kirigaoka Tsuda Hospital
Division name
Pulmonary Rehabilitation center
Zip code
802-0052
Address
3-9-20, Kirigaoka, Kokurakita, Kitakyusyu, Fukuoka
TEL
093-921-0438
Homepage URL
k.shingai@hotmail.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Nagasaki University
Address
1-7-1, Sakamoto, Nagasaki, Japan
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23110904
Org. issuing International ID_1
Nagaski University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
霧ヶ丘つだ病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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
29
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
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060377
