Unique ID issued by UMIN | UMIN000015619 |
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Receipt number | 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 10:47:03 |
Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Evaluation of a newly developed facemask for oxygen administration: a crossover study in healthy volunteers
Japan |
healthy adult volunteers
Anesthesiology | Adult |
Others
NO
The purpose of this study is to compare the efficacy of the newly developed facemask with the conventional facemask for oxygen administration.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The primary outcome is to evaluate respiratory gas exchange including end tidal CO2/O2 concentrations and discomfortness when wearing the new facemask.
The secondary outcome is to evaluate frequency of adverse events when wearing the new facemask.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
2
Treatment
Device,equipment |
Wearing the newly developed facemask
Wearing the conventonal facemask
20 | years-old | <= |
Not applicable |
Male and Female
Male and female volunteers providing written informed consent not youger than 20 years old (at the time of informed consent)
(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
10
1st name | |
Middle name | |
Last name | Takashi Kondo |
Hiroshima University Hospital
Department of Anesthesiology and Critical Care
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
082-257-5267
yrdcn850@yahoo.co.jp
1st name | |
Middle name | |
Last name | Takashi Kondo |
Hiroshima University Hospital
Department of Anesthesiology and Critical Care
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
082-257-5267
yrdcn850@yahoo.co.jp
Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Self funding
NO
2014 | Year | 11 | Month | 10 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 21 | Day |
2014 | Year | 11 | Month | 15 | Day |
2014 | Year | 11 | Month | 06 | Day |
2015 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016825
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