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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020415
Receipt No. R000023577
Scientific Title Evaluation of O2 and CO2 concentration by the difference of mask form
Date of disclosure of the study information 2016/01/04
Last modified on 2016/01/21

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Basic information
Public title Evaluation of O2 and CO2 concentration by the difference of mask form
Acronym Mask form diference for O2 and CO2 evaluation
Scientific Title Evaluation of O2 and CO2 concentration by the difference of mask form
Scientific Title:Acronym Mask form diference for O2 and CO2 evaluation
Region
Japan

Condition
Condition Patient who had undergone general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of oygen mask form difference for oxygen administration
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oxygen administration efficacy
Oxygen concentration
CO2 concentrartion
Key secondary outcomes comfort

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Conventional oxygen mask
Interventions/Control_2 Newly developed oxygen mask
(Sentri Ecolite 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
80 years-old >
Gender Male and Female
Key inclusion criteria Patient who recovered from anesthesia
Key exclusion criteria Patient who has low pulmonary fucntion
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 0726-84-6361
Email ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyasu Komasawa
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7Daigaku-machi, Takatsuki city
TEL 0726-84-6361
Homepage URL
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
Address
Tel
Email

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
Ecolite provided significant higher PaO2 han conventional PaCO2. 
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
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
2016 Year 01 Month 20 Day
Date of closure to data entry
2016 Year 01 Month 22 Day
Date trial data considered complete
2016 Year 01 Month 23 Day
Date analysis concluded
2016 Year 01 Month 24 Day

Other
Other related information Ecolie provided significnt smaller PaCO2 and high EtCO2 than convnetional PVC mask.

Management information
Registered date
2016 Year 01 Month 01 Day
Last modified on
2016 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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