UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical investigation of air environment of operating rooms and body temperature by the new air conditioning system
Title of the study (Brief title)	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	Mitsuhiro Narushima
Organization	TMG Asaka Medical Center
Division name	Division of Aneshtesiology
Address	1340-1 Mizonuma, Asaka-City, Saitama-Pref, Japan
TEL	048-466-2055
Email	m_narushima@tmg.or.jp

Public contact
Name of contact person	Mitsuhiro Narushima
Organization	TMG Asaka Medical Center
Division name	Division of Aneshtesiology
Address	1340-1 Mizonuma, Asaka-City, Saitama-Pref, Japan
TEL	048-466-2055
Homepage URL
Email	m_narushima@tmg.or.jp

Sponsor
Institute	TMG Asaka Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037892