UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042524 |
|---|---|
| Receipt number | R000048544 |
| Scientific Title | Investigation of the Safety and Efficacy of Oxygen Administration over a Surgical Facemask |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2023/11/27 14:29:27 |
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Basic information
Public title
Investigation of the Safety and Efficacy of Oxygen Administration over a Surgical Facemask
Acronym
Investigation of the Safety and Efficacy of Oxygen Administration over a Surgical Facemask
Scientific Title
Investigation of the Safety and Efficacy of Oxygen Administration over a Surgical Facemask
Scientific Title:Acronym
Investigation of the Safety and Efficacy of Oxygen Administration over a Surgical Facemask
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Anesthesiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the anesthetic management of patients with novel coronavirus infection, it is recommended that a surgical mask be placed on the patient after extubation and an oxygen mask be placed over the surgical mask. However, data on safety and effectiveness have not been presented. Therefore, we will examine the fraction of inhaled oxygen (FIO2), partial pressure of inhaled carbon dioxide (PICO2), and transcutaneous oxygen saturation (SpO2) when oxygen is administered by wearing an oxygen mask over a surgical mask.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIO2, PICO2, SpO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
with a surgical facemask
Interventions/Control_2
without a surgical 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
respiratory disease, cardiovascular disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Center for Perioperative Survices and Critical Care
Zip code
8130017
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
TEL
092-682-7000
umin-ctr@dafch.org
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Center for Perioperative Survices and Critical Care
Zip code
8130017
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
TEL
092-682-7000
Homepage URL
umin-ctr@dafch.org
Sponsor or person
Institute
Fukuoka Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Children's 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
IRB, Fukuoka Children's Hospital
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
Tel
092-682-7000
k-keiei@fcho.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 | 24 | Day |
Related information
URL releasing protocol
https://jsa-shoroku.jp/search/detail_program/id:2847
Publication of results
Unpublished
Result
URL related to results and publications
https://jsa-shoroku.jp/search/detail_program/id:2847
Number of participants that the trial has enrolled
10
Results
FIO2 in the SM+ group was significantly lower than that in the SM- group at oxygen flow rates of 6L/min, 8L/min, and 10L/min. (PICO2 was significantly higher in the SM+ group than in the SM- group when the oxygen mask was not worn, and SpO2 was not significantly different between the two groups under all conditions.
Results date posted
| 2023 | Year | 11 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adult
Participant flow
volunteers
Adverse events
No adverse events related to the study were observed.
Outcome measures
FIO2, PICO2, and SpO2
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | 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 | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048544
