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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015619
Receipt No. R000016825
Scientific Title Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Date of disclosure of the study information 2014/11/10
Last modified on 2015/11/30

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Basic information
Public title Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Acronym Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Scientific Title Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Scientific Title:Acronym Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Region
Japan

Condition
Condition healthy adult volunteers
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the efficacy of the newly developed facemask with the conventional facemask for oxygen administration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome is to evaluate respiratory gas exchange including end tidal CO2/O2 concentrations and discomfortness when wearing the new facemask.
Key secondary outcomes The secondary outcome is to evaluate frequency of adverse events when wearing the new facemask.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Wearing the newly developed facemask
Interventions/Control_2 Wearing the conventonal facemask
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 volunteers providing written informed consent not youger than 20 years old (at the time of informed consent)

Key exclusion criteria (1) Subjectss with a pulmonary disease
(2) Pregnant women and women suspected of being pregnant
(3) Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takashi Kondo
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5267
Email yrdcn850@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Kondo
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5267
Homepage URL
Email yrdcn850@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology and Critical Care, Hiroshima University Hospital
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
2014 Year 11 Month 10 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
2014 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 06 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016825

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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