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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042966 |
Receipt No. | R000049052 |
Scientific Title | Evaluation of the usefulness of using the pulse oximeter sideways |
Date of disclosure of the study information | 2021/01/12 |
Last modified on | 2021/01/11 |
Basic information | ||
Public title | Evaluation of the usefulness of using the pulse oximeter sideways | |
Acronym | Evaluation of the usefulness of using the pulse oximeter sideways | |
Scientific Title | Evaluation of the usefulness of using the pulse oximeter sideways | |
Scientific Title:Acronym | Evaluation of the usefulness of using the pulse oximeter sideways | |
Region |
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Condition | ||
Condition | none | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the equivalence of the regular pulse oximeter wearing method and the sideways wearing method in adults. |
Basic objectives2 | Others |
Basic objectives -Others | none |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Evaluate the equivalence of SpO2 between the regular wearing method on the left index finger and the sideways wearing method on the right index finger. |
Key secondary outcomes | Evaluate the equivalence of SpO2 between the regular mounting method for the left index finger and the lateral mounting method for the right index finger with the black nail tip.
The relationship between the patient background / physical findings and the regular wearing method on the left index finger and the sideways wearing method on the right index finger will be examined. |
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 | |
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Interventions/Control_4 | |
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Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Adults over 20 years old
2. Those who have obtained consent for this research by signing the consent form by the person himself / herself. |
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Key exclusion criteria | 1. Those who cannot attach a pulse oximeter to their fingers.
2. Those who have different SpO2 values measured by the regular wearing method of the left index finger and the regular wearing method of the right index finger. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hamamatsu University | ||||||
Division name | Department of Cardiology | ||||||
Zip code | 431-3192 | ||||||
Address | 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan | ||||||
TEL | 053-435-2267 | ||||||
ymaekawa@hama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hamamatsu University | ||||||
Division name | Department of Cardiology | ||||||
Zip code | 431-3192 | ||||||
Address | 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan | ||||||
TEL | 053-435-2267 | ||||||
Homepage URL | |||||||
doug1031@hama-med.ac.jp |
Sponsor | |
Institute | Department of Cardiology, Hamamatsu University |
Institute | |
Department |
Funding Source | |
Organization | Department of Cardiology, Hamamatsu University |
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 of Hamamatsu University School of Medicine |
Address | 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan |
Tel | 053-435-2680 |
rinri@hama-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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | none |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049052 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |