UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019495
Receipt number R000022543
Scientific Title Prospective study to evaluate oxygen saturation before and after pulmonary resection using consecutive pulse oximetry
Date of disclosure of the study information 2015/10/26
Last modified on 2015/10/26 10:11:35

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Basic information

Public title

Prospective study to evaluate oxygen saturation before and after pulmonary resection using consecutive pulse oximetry

Acronym

Prospective study to evaluate oxygen saturation before and after pulmonary resection using consecutive pulse oximetry

Scientific Title

Prospective study to evaluate oxygen saturation before and after pulmonary resection using consecutive pulse oximetry

Scientific Title:Acronym

Prospective study to evaluate oxygen saturation before and after pulmonary resection using consecutive pulse oximetry

Region

Japan


Condition

Condition

before and after pulmonary
resection

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

For the case that pulmonary
resection in our department is planned, to assess association of oxygen saturation (SPO2) and before and after the operation with consecutive pulse oximetry.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Variation of the oxygen saturation before and after pulmonary resection

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Utilization of consecutive pulse oximetry before and after the operation

Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients maintaining the functions of the main organs.
2.A case that an operation under the general anesthesia is possible.
3.A case that a document agrrement by the examination participation.

Key exclusion criteria

1.Age is a patient younger than 20 years at the agreement acquisition.
2.Emergency surgery case
3.Patients with severe or complicated medical conditions, not allowing participation into this protocol

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takamasa Onuki

Organization

Tokyo Women's Medical University of Medicine

Division name

Department of Surgery I

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

s1ikyoku.cl@twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Miyano

Organization

Tokyo Women's Medical University of Medicine

Division name

Department of Surgery I

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Homepage URL


Email

s1ikyoku.cl@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University of Medicine, Department of Surgery I

Institute

Department

Personal name



Funding Source

Organization

None

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


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

東京女子医科大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 26 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

Preinitiation

Date of protocol fixation

2015 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 26 Day

Last follow-up date


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 26 Day

Last modified on

2015 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022543


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name