UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026218
Receipt number R000030102
Scientific Title Investigation of Oxygen Reserve Index (ORI) during one lung ventilation
Date of disclosure of the study information 2017/03/02
Last modified on 2023/09/22 07:30:55

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Basic information

Public title

Investigation of Oxygen Reserve Index (ORI) during one lung ventilation

Acronym

Oxygen Reserve Index (ORI) during one lung ventilation

Scientific Title

Investigation of Oxygen Reserve Index (ORI) during one lung ventilation

Scientific Title:Acronym

Oxygen Reserve Index (ORI) during one lung ventilation

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Chest surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the usefulness of ORI to detect the inadvertent endobronchial intubation during surgery.

Basic objectives2

Others

Basic objectives -Others

to evaluates the relationship between ORI and Pao2 during OLV.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in ORI, SpO2,PaO2 before and after one lung ventilation

Key secondary outcomes

the relationship between ORI and Pao2 during OLV


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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 scheduled for pneumonectomy who needs one-lung ventuilation during surgery
2) ASA (American Society of Anesthesiologists) classification 1 or 2

Key exclusion criteria

1. Patient performed CT-guided marking prior to surgery
2. In case where ORI isn`t indicated
3. In case where SpO2 can`t be kept >92% during the research
4. Ineligibility for participation in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name MOTOI
Middle name
Last name KUMAGAI

Organization

Iwate Medical University Hospital

Division name

Department of Anaesthesiology

Zip code

020-0021

Address

19-1, Uchimaru, Morioka, Iwate, Japan

TEL

+81196515111

Email

bear@kxd.biglobe.ne.jp


Public contact

Name of contact person

1st name Motoi
Middle name
Last name Kumagai

Organization

Iwate Medical University Hospital

Division name

Department of Anaesthesiology

Zip code

020-0021

Address

19-1, Uchimaru, Morioka, Iwate, Japan

TEL

+81196515111

Homepage URL


Email

bear@kxd.biglobe.ne.jp


Sponsor or person

Institute

Iwate Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Iwate Medical University Hospital

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

Iwate medical university hospital

Address

2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate,Japan

Tel

0196137111

Email

motoij@iwate-med.ac.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

2017 Year 03 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

2017 Year 03 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 01 Day

Last follow-up date

2017 Year 06 Month 30 Day

Date of closure to data entry

2017 Year 07 Month 10 Day

Date trial data considered complete

2017 Year 07 Month 20 Day

Date analysis concluded

2017 Year 08 Month 31 Day


Other

Other related information

waiting for a decision of IRB


Management information

Registered date

2017 Year 02 Month 20 Day

Last modified on

2023 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name