UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057654 |
|---|---|
| Receipt number | R000065874 |
| Scientific Title | An observational study on the relationship between tissue oxygen saturation and mottling score measured by a finger-mounted oximeter, shock withdrawal time, mortality, and ICU length of stay in critically ill patients. |
| Date of disclosure of the study information | 2025/04/18 |
| Last modified on | 2025/04/18 18:39:41 |
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Basic information
Public title
Observational study of tissue oxygen saturation measurement using a finger-mounted oximeter for critically ill patients
Acronym
Observational study of tissue oxygen saturation measurement in critically ill patients
Scientific Title
An observational study on the relationship between tissue oxygen saturation and mottling score measured by a finger-mounted oximeter, shock withdrawal time, mortality, and ICU length of stay in critically ill patients.
Scientific Title:Acronym
Observational study of tissue oxygen saturation using a finger-mounted in critically ill patients
Region
| Japan |
Condition
Condition
circulatory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between tissue oxygen saturation and mottling score, time to shock withdrawal, mortality, and ICU length of stay in patients with circulatory failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
shock withdrawal time, mortality rate, ICU stay time
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Systolic blood pressure below 90 mmHg or lactate above 2 mmol/L at the time of arrival at the hospital
Key exclusion criteria
Patients who had received cardiopulmonary resuscitation, those under 20 years of age, and those who were unable to consent to this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Sato |
Organization
Nihon University School of Medicine
Division name
Division of Emergency and Critical Care Medicine, Department of Acute Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kami-cho Itabashi-ku, Tokyo
TEL
03-3972-8111
sato.jun@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Sato |
Organization
Nihon University School of Medicine
Division name
Division of Emergency and Critical Care Medicine, Department of Acute Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kami-cho Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
sato.jun@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Jun Sato
Funding Source
Organization
Nothing
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
Ethics Committee of Nihon University Hospital
Address
1-6, Kanda Surugadai, Chiyoda-ku, Tokyo-to
Tel
03-3293-1711
sato.jun@nihon-u.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
| 2025 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2075-4418/14/21/2428
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/14/21/2428
Number of participants that the trial has enrolled
38
Results
In patients with circulatory failure, subcutaneous tissue oxygen saturation did not correlate with blood pressure but showed a significant negative correlation with the SOFA score. In particular, measurement of subcutaneous tissue oxygen saturation at the knee was valid.
Results date posted
| 2025 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
The median age was 73 years, and septic shock accounted for 18 cases (47%).
Participant flow
A total of 259 patients met the selection criteria, 129 cases of cardiac arrest were excluded, and 92 cases for which consent could not be obtained were also excluded, resulting in a final analysis of 38 cases.
Adverse events
none
Outcome measures
Correlation between tissue oxygen saturation, blood pressure, and SOFA score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation parameters include vital signs, blood test results, mottling score, subcutaneous and cerebral tissue oxygen saturation, etc.
Management information
Registered date
| 2025 | Year | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065874
