UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057280 |
|---|---|
| Receipt number | R000065476 |
| Scientific Title | The differences in oxygen saturation measured by pulse oximeters on the finger and ear in the Trendelenburg position: a prospective observational study |
| Date of disclosure of the study information | 2025/03/13 |
| Last modified on | 2025/11/24 16:41:48 |
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Basic information
Public title
Does Oxygen Saturation Differ Between the Finger and Ear in the Head-Down Position?
Acronym
OXYHEAD (OXYgen HEAD-down)
Scientific Title
The differences in oxygen saturation measured by pulse oximeters on the finger and ear in the Trendelenburg position: a prospective observational study
Scientific Title:Acronym
FETOX (Finger Ear Trendelenburg Oximetry eXperimental study)
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the differences in oxygen saturation measured by pulse oximeters on the fingertip and earlobe in the Trendelenburg position.
Basic objectives2
Others
Basic objectives -Others
measurement accuracy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
SpO2 (fingertip), SpO2 (earlobe)
Key secondary outcomes
SaO2
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
Key inclusion criteria
Patients scheduled to undergo robot-assisted radical prostatectomy
Key exclusion criteria
Patients with lung diseases that are expected to have a significant impact on oxygen saturation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Uehara |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Department of Anesthesiology
Zip code
740-8510
Address
Iwakuni Clinical Center, 1-1-1, Atagocho, Iwakuni, Yamaguchi 740-8510, Japan
TEL
0827-34-1000
kuehara@dune.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Uehara |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Department of Anesthesiology
Zip code
740-8510
Address
Iwakuni Clinical Center, 1-1-1, Atagocho, Iwakuni, Yamaguchi 740-8510, Japan
TEL
0827-34-1000
Homepage URL
kuehara@dune.ocn.ne.jp
Sponsor or person
Institute
National Hospital Organization Iwakuni Clinical Center
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Ethics Committee, National Hospital Organization Iwakuni Clinical Center
Address
Iwakuni Clinical Center, 1-1-1, Atagocho, Iwakuni, Yamaguchi 740-8510, Japan
Tel
0827-35-5684
513-rinsyokenkyu@mail.hosp.go.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
| 2025 | Year | 03 | Month | 13 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study type
Observational
Eligibility Criteria
Patients undergoing robotic-assisted total prostatectomy March-October 2025
Outcome measure
SpO2 (fingertip, earlobe), SaO2
Management information
Registered date
| 2025 | Year | 03 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065476
