UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019586
Receipt number R000022642
Scientific Title Change of transcutaneous oxygen tension in the trunk and extremities with hyperbaric oxygen therapy
Date of disclosure of the study information 2015/10/31
Last modified on 2024/03/14 09:08:48

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Basic information

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

Condition

healthy subjects

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Tokyo Medical and Dental University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University Faculty of Medicine

Organization

Division

Category of Funding Organization

Other

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

2015 Year 10 Month 31 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 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

Other related information



Management 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


Research Plan
Registered date File name
2018/11/05 健常HBO血流計画書改訂版v3.doc

Research case data specifications
Registered date File name
2016/11/02 体幹四肢酸素分圧被験者.xlsx

Research case data
Registered date File name
2016/11/02 経皮酸素分圧データ.pptx