UMIN-CTR Clinical Trial

Public title

Change of transcutaneous oxygen tension in the trunk and extremities with hyperbaric oxygen therapy

Acronym

Change of tcPO2 in the trunk and extremities with HBO2

Scientific Title

Change of transcutaneous oxygen tension in the trunk and extremities with hyperbaric oxygen therapy

Scientific Title:Acronym

Change of tcPO2 in the trunk and extremities with HBO2

Region

Japan

Condition

healthy subjects

Classification by specialty

Orthopedics

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To test the different effects for transcutaneous oxygen tension in the trunk and extremities with different pressure or shape of oxygen mask during hyperbaric oxygen conditions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluate differences of transcutaneous oxygen tension under the condition 2.0 and 2.5 ATA
or with different shapes of oxygen masks

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

8

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

HBO:2.5 ATA for 60 minutes with oxygen inhalation with oxygen mask by intermed Japan
1 hour and 45 minutes including compression and depression.
HBO application once a day

Interventions/Control_2

HBO:2.5 ATA for 60 minutes with oxygen inhalation with oxygen mask by intermed Japan
1 hour and 45 minutes including compression and depression. HBO application once a day

Interventions/Control_3

HBO:2.5 ATA for 60 minutes with oxygen inhalation with oxygen mask by INTERSURGICAL COMPLETE RESPIRATORY SYSTEMS
1 hour and 45 minutes including compression and depression. HBO application once a day

Interventions/Control_4

HBO:2.5 ATA for 60 minutes with oxygen inhalation with oxygen mask by NIHON medical next
1 hour and 45 minutes including compression and depression. HBO application once a day

Interventions/Control_5

HBO:2.0 ATA for 60 minutes with oxygen inhalation with oxygen mask by intermed Japan
1 hour and 45 minutes including compression and depression.HBO application once a day

Interventions/Control_6

HBO:2.0 ATA for 60 minutes with oxygen inhalation with oxygen mask by intermed Japan
1 hour and 45 minutes including compression and depression.
HBO application once a day

Interventions/Control_7

HBO:2.0 ATA for 60 minutes with oxygen inhalation with oxygen mask by INTERSURGICAL COMPLETE RESPIRATORY SYSTEMS
1 hour and 45 minutes including compression and depression. HBO application once a day

Interventions/Control_8

HBO:2.0 ATA for 60 minutes with oxygen inhalation with oxygen mask by NIHON medical next
1 hour and 45 minutes including compression and depression. HBO application once a day

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>=

Gender

Male and Female

Key inclusion criteria

40 healthy subjects

Key exclusion criteria

1. healthy subjects with no consent
<HBO Contra-indication>
healthy subjects with
1)impossible for equalizing pressure of the ear
2)claustrophobia
3)possibility of pregnancy
4)congenital pulmonary cystic diseases, and past history of pneumothorax

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Kazuyoshi Yagishita

Organization

Medical Hospital of Tokyo Medical and Dental University

Division name

Hyperbaric Medical Center/ Sports Medicine Clinical Center

Zip code

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

0358035341

Email

yagishita.orth@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazuyoshi Yagishita

Organization

Medical Hospital of Tokyo Medical and Dental University

Division name

Hyperbaric Medical Center/ Sports Medicine Clinical Center

Zip code

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

0358035341

Homepage URL

Email

yagishita.orth@tmd.ac.jp

Institute

Tokyo Medical and Dental University Faculty of Medicine

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University Faculty of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

12

Month

25

Day

Date of IRB

2014

Year

12

Month

15

Day

Anticipated trial start date

2015

Year

03

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

31

Day

Last modified on

2024

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022642

Single case data URL

Value
https://center6.umin.ac.jp/ice/22642