UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020422 |
|---|---|
| Receipt number | R000019786 |
| Scientific Title | Crossover test to compare the efficacy of new oxygen mask with existing one in patients in surgical intensive care unit |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2019/08/07 13:33:54 |
* 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
Crossover test to compare the efficacy of new oxygen mask with existing one in patients in surgical intensive care unit
Acronym
Crossover test of new oxygen mask
Scientific Title
Crossover test to compare the efficacy of new oxygen mask with existing one in patients in surgical intensive care unit
Scientific Title:Acronym
Crossover test of new oxygen mask
Region
| Japan |
Condition
Condition
digestive disorder
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of new oxygen mask with existing one.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of new oxygen mask
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A:Use new oxygen mask
B:Use existing oxygen mask
Intervention1:A(10min)-washout(10min)-B(10min)
Interventions/Control_2
Intervention2:B(10min)-washou(10min)t-A(10min)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients in surgical intensive care unit after operations
Key exclusion criteria
Patients with respiratory disorder.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiko Otsuki |
Organization
Hiroshima university hospital
Division name
Department of anesthesiology
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5267
sachi85@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Otsuki |
Organization
Hiroshima university hospital
Division name
Department of anesthesiology
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5267
Homepage URL
sachi85@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology of Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology of Hiroshima university 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
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
| 2016 | Year | 01 | 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
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
| 2015 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019786
