UMIN-CTR Clinical Trial

Basic information
Public title	The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Acronym	The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Scientific Title	The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Scientific Title:Acronym	The Impact of Surgical Masks on Oxygen Therapy with Oxygen Masks
Region	Japan

Condition
Condition	Adult Healthy Volunteers
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine whether a surgical mask under an oxygen mask will affect oxygen therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The fraction of inspired oxygen (FiO2) , The partial pressure of inspired carbon dioxide
Key secondary outcomes	The fraction of exhaled oxygen, The partial pressure of exhaled carbon dioxide, Percutaneous arterial oxygen saturation(SpO2)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Wearing an oxygen mask with a surgical mask
Interventions/Control_2	Wearing an oxygen mask without a surgical mask
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	Male and female adult volunteers aged 20 years or older with ASA(American Society of Anesthesia) PS(Physical Status) 1-2 with no underlying respiratory diseases and Hugh-Jones classification grade I
Key exclusion criteria	ASA PS3 or higher Underlying respiratory disease and a Hugh-Jones classification of grade II or higher
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Michiko Middle name Last name Kinoshita
Organization	Tokushima University Hospital
Division name	Anesthesiology
Zip code	770-8503
Address	2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL	088-633-7181
Email	michiko-kinoshita@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Michiko Middle name Last name Kinoshita
Organization	Tokushima University Hospital
Division name	Anesthesiology
Zip code	770-8503
Address	2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL	088-633-7181
Homepage URL
Email	michiko-kinoshita@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital, Anesthesiology
Institute
Department

Funding Source
Organization	Tokushima University Hospital, Anesthesiology
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	The Ethics Committee of Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
Tel	088-633-7181
Email	michiko-kinoshita@tokushima-u.ac.jp

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	2020 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	15
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	2020 Year 11 Month 01 Day
Date of IRB	2020 Year 11 Month 09 Day
Anticipated trial start date	2020 Year 11 Month 26 Day
Last follow-up date	2022 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	2020 Year 11 Month 26 Day
Last modified on	2022 Year 06 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048575