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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name