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
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
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
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
