UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033233 |
|---|---|
| Receipt number | R000037892 |
| Scientific Title | A clinical investigation of air environment of operating rooms and body temperature by the new air conditioning system |
| Date of disclosure of the study information | 2018/07/02 |
| Last modified on | 2018/07/02 10:02:13 |
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Basic information
Public title
A clinical investigation of air environment of operating rooms and body temperature by the new air conditioning system
Acronym
A clinical investigation of operating rooms environment by the new air conditioning system
Scientific Title
A clinical investigation of air environment of operating rooms and body temperature by the new air conditioning system
Scientific Title:Acronym
A clinical investigation of operating rooms environment by the new air conditioning system
Region
| Japan |
Condition
Condition
Disease to be applied surgical operation
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Despite numerical and objective evaluation of the influence on the operating room environment by the new air conditioning system up to the computational and laboratory level, it has not been evaluated in practical clinical practice. We will survey room environment (temperature / dust / electric energy) in the new air conditioning system and associated patient's body temperature change and user's senses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Temperature / dust / electric energy / patient's body temperature change
Key secondary outcomes
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 undergoing surgery in the operating room
Key exclusion criteria
Nothing particular
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Narushima |
Organization
TMG Asaka Medical Center
Division name
Division of Aneshtesiology
Zip code
Address
1340-1 Mizonuma, Asaka-City, Saitama-Pref, Japan
TEL
048-466-2055
m_narushima@tmg.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Narushima |
Organization
TMG Asaka Medical Center
Division name
Division of Aneshtesiology
Zip code
Address
1340-1 Mizonuma, Asaka-City, Saitama-Pref, Japan
TEL
048-466-2055
Homepage URL
m_narushima@tmg.or.jp
Sponsor or person
Institute
TMG Asaka Medical Center
Institute
Department
Personal name
Funding Source
Organization
TMG Asaka Medical Center
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
| 2018 | Year | 07 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross sectional Study.
The recruitment method of the subjects was the patient who underwent surgery at the institution in July 2018.
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037892
